Early Detection Research Network

Sites

Institutions and PIs in EDRN.

Biomarker Developmental Laboratories

Breast and Ovarian

Investigator Site
Fred Hutchinson Cancer Research Center
Baylor College of Medicine
A Unique Approach Combining Avatar Mice and Targeted Mass Spectrometry to Identify Blood Biomarkers for Early Detection of Breast Cancer
Project Summary

Tens of millions of women undergo population-based screening for breast cancer by mammography. Despite the life-saving potential of early detection, s...

Tens of millions of women undergo population-based screening for breast cancer by mammography. Despite the life-saving potential of early detection, screening guidelines for mammography are controversial and continue to evolve. At issue are the specificity of mammography for distinguishing benign vs cancerous lesions, the sensitivity of mammography in some patient populations (e.g. women with dense breasts), and concerns regarding over-diagnosis (e.g. some ductal carcinoma in situ). Our ultimate clinical aim is to develop a blood test for early detection of breast cancer that can be used in conjunction with mammography to improve sensitivity and specificity during screening, and thus have enormous clinical impact by detecting treatable cancers missed by mammography (reducing mortality) and by avoiding unnecessary invasive procedures for benign or non-life-threatening disease. <br>Despite considerable effort, attempts to identify blood-based screening biomarkers for early detection of breast cancer have failed, due to technological and methodological limitations. Clearly new approaches are warranted. We are proposing a completely novel strategy, based on the initial discovery of candidate biomarkers in the plasma of “avatar mice” (harboring early passage human breast cancer xenografts), and followed by biomarker triage and validation using a novel biomarker pipeline based on a targeted form of mass spectrometry (MS), multiple reaction monitoring (MRM). If successful, this study could provide a road map for applying this general approach to other cancer sites, beyond breast cancer.<br>Briefly, candidate circulating biomarkers identified in the avatar mouse plasma will be verified in the plasma from the human patients and prioritized for further testing based on integrative proteo-genomic analyses using large breast cancer datasets generated by NCI genomic and proteomic consortia (TCGA and CPTAC). A novel, multiplex MRM-based assay will be developed and analytically validated (according to established fit-forpurpose guidelines) to quantify up to 50-100 prioritized biomarker candidates. Candidate biomarkers will be evaluated in an existing, strongly unbiased collection of plasma samples in which plasmas were collected prior to biopsy, compliant with PRoBE study design criteria, under an SOP from women with undiagnosed mammographic lesions. Performance of the candidate biomarkers will initially be assessed in a training set (100 cases, 100 controls) to verify which candidates show a mean difference in plasma levels between cases vs controls, and to test the possibility of building a multiple marker prediction model. Subsequently, individual candidate biomarkers (as well as a potential multiple marker prediction model) will be assessed in an independent validation set (150 cases, 150 controls) to estimate the sensitivity and specificity of the markers/panel. <br>

Investigator Site
Duke University Medical Center
Creatv MicroTech Inc.
Breast Cancer Detection Consortium
Project Summary

Mammography is an early detection modality for breast cancer that is implemented widely in the United States, has established benchmarks of performanc...

Mammography is an early detection modality for breast cancer that is implemented widely in the United States, has established benchmarks of performance, and in most studies throughout the world has been demonstrated to reduce mortality due to the disease. This relatively inexpensive x-ray imaging of the breast also provides a location that can be directly sampled through needle biopsy which leads generally to an unambiguous pathologic diagnosis of invasive cancer, carcinoma in situ, or benign findings. No system is perfect and mammographic screening, particularly in the US, prompts over 1.6 million biopsies per year detecting approximately 230,000 invasive and 60,000 non-invasive cancers for a positive predictive value of less than 20%. There may be substantial room to improve on this and reduce the number of biopsies but this improvement must not sacrifice detection rates so the negative predictive value (NPV, identification of true negatives) must remain very high. In this Biomarker Development Laboratory application, we propose to test whether a combination of mammographic feature analysis and candidate biomarkers that we have identified can achieve an NPV that would be acceptable to patients and providers to prevent unnecessary breast biopsies. One of the biomarkers is a type of circulating giant cell termed “Cancer Associated Macrophage Like” (CAML) that can only be detected using freshly drawn whole blood, we propose to conduct a prospective trial at Duke University in women undergoing breast cancer diagnosis. Our realistic goal is to accrue ~1000 women over the course of 4 years for which full field digital mammography has been performed. The images will undergo feature extraction for decision modeling. Blood will be analyzed for the presence and type of CAML cells, immunosignaturing using the high density peptide arrays developed by Stephen Johnston at Arizona State, and measurements of two specific analytes that have the highest sensitivity and specificity for basal type cancers, CA125 and TP53 autoantibodies. As feature analysis from imaging alone can achieve, at least for masses on mammography, an AUC of ~0.9, the study is designed to determine whether the biomarkers have sufficient complementary information to the imaging and each other to increase the AUC to 0.95 allowing us to identify a threshold where there is a 98% NPV. We will make use of the most careful and consistent standard operating procedures, the best candidate biomarkers, and the most well developed imaging algorithms to make this a definitive study.

Investigator Site
Arizona State University
Arizona State University
Novel Approaches to Study Immune Responses to Post Translational Modifications for Cancer Detection
Project Summary

Despite advances in screening and treatment, mortalities from breast and lung cancers have remained high in the US over the last 20 years. It is widel...

Despite advances in screening and treatment, mortalities from breast and lung cancers have remained high in the US over the last 20 years. It is widely accepted that early detection is critical to improving outcomes in both diseases. Both also rely on imaging for screening, but false positive and false negative detection are associated with unnecessary biopsies, missed diagnoses, and costs. There is an urgent need for biochemical markers that improve the performance of imaging technologies. Our laboratories have been successful at identifying useful cancer biomarkers by exploiting patients’ own ability to produce antibodies against tumorassociated antigens (TAA), referred to as tumor-associated autoantibodies (TAAb). With prior EDRN support, we developed high-throughput programmable protein display methods for the rapid detection and validation of autoantibody biomarker signatures in breast and lung cancers. Our breast cancer TAAb biomarkers have been licensed and integrated into Videssa™ Breast that is now available as CLIA-certified test. Our triple negative breast cancer markers have been validated in blinded phase 2 multicenter validation studies. These demonstrate the great utility of TAAb in cancer early detection. However, the sensitivities of most TAAbs is moderate and there is a suggestion that greater sensitivity and specificity could be obtained by examining TAAb directed at aberrantly modified proteins in cancers. Our central hypothesis is that aberrant protein glycosylation, a hallmark of breast and lung cancers, induces glycoprotein-specific TAAb that can be measured as specific serum biomarkers of these cancers. Alterations in glycosylation are highly immunogenic, and there is strong historical evidence for significant antibody responses to cancer-altered glycoproteins. However, all current protein (or polypeptide) display tools allow limited or no post-translational modification. This historical roadblock has prevented the identification of these biomarkers because of the lack of screening methods that test immunogenic structural glycoproteins. We introduce a tool for the high-throughput display of full-length proteins decorated with cancer-specific O-glycan structures. This will revolutionize the opportunity to screen glycan-protein epitopes in their natural context. Our team comprises strong expertise in functional proteomics, biomarker development, glycoproteomics, medical oncology and biostatistics. Targeted proteins will include: the extra-cellular domains of relevant single pass membrane proteins, proteins known to be O-glycosylated and overexpressed in the two cancers, and all known mucins. They will be translated in situ using human ribosomes and chaperone proteins and then systematically decorated with Tn and STn O-GalNAc-type glycans by consecutive addition of recombinant glycosyltransferases and sugar nucleotides to mirror what occurs in the two cancers. Adhering to the principles of PRoBE design, we will screen these arrays with cancer patient and control sera. Our study will focus on cancer patients and non-cancer subjects with positive imaging findings. Study design will include Phase I discovery (arrays/ELISA) and Phase II validation using ELISA.

Colon and Esophagus

Investigator Site
Case Western Reserve University
Fred Hutchinson Cancer Research Center
Case Western Reserve University
Biomarkers for Reducing Mortality of Cancers of the Colon and Esophagus
Project Summary

The goal of this EDRN renewal proposal is the discovery and validation of biomarkers for reducing mortality from gastrointestinal cancers. We particul...

The goal of this EDRN renewal proposal is the discovery and validation of biomarkers for reducing mortality from gastrointestinal cancers. We particularly target cancers of the colon (CRC), the second leading cause of U.S. cancer deaths, and adenocarcinomas of the esophagus (EAC), the fastest increasing cause of U.S. cancer deaths. In our first funding period, our group prominently advanced early detection of colon cancers through detection of aberrantly methylated tumor DNA in stools. Our work testing methylated VIM (M-VIM) DNA in stools led to an EDRN prospective validation study (GLNE-10), a commercial colon cancer test (ColoSure, from Exact Sciences & LabCorp), and to proof of principal for the Exact Cologuard test of methylated stool DNA that is now FDA approved. Our work studying the 15-PGDH tumor suppressor gene identified the first biomarker for personalized chemoprevention, showing NSAIDs lower colon cancer risk only in individuals with high, but not low, colon 15-PGDH expression. And our further studies of M-VIM showed this biomarker to also be highly sensitive and specific for detecting Barrett’s esophagus (BE) and EAC, specifically in tests using esophageal brushings. In this renewal application, for colon cancer we propose EDRN phase 2 validation studies testing biomarkers that identify individuals at high risk of developing colon cancer by testing normal colon mucosa for RNA and DNA markers of elevated cancer risk that are: a) low levels of 15-PGDH transcript expression, and/or b) high levels of DNA methylation at specific colon cancer risk loci. For EAC, we first propose an EDRN phase 2 validation study testing sensitivity and specificity of a panel of candidate DNA methylation biomarkers for identifying BE, the currently best recognized marker of EAC susceptibility, in assays of samples collected from esophageal brushings. We follow these BE assays by then proposing an EDRN phase 2 study of a set of markers that detect EAC, and its precursor lesion HGD, while not detecting BE, thus providing surveillance markers for catching early BE progression, again by testing samples from esophageal brushings. Our candidate progression marker panel includes DNA loci we find aberrantly methylated in HGD and EAC (but not BE); novel non-coding lincRNAs we find highly expressed in EAC (but not in BE); and mutations in TP53. We also further test the ability of this panel to discriminate low grade BE dysplasias (LGD) that are or are not associated with progression to HGD and EAC. Last, we propose new biomarker discovery to identify methylated DNA and/or RNA biomarkers that, in esophageal brushings, will detect the minority subset of EAC or HGD that are negative for our current EAC/HGD marker panel. Our goals are to: 1) develop effective risk stratification assays to optimize primary prevention of CRC; and 2) replace the current ineffective paradigm for preventing EAC deaths by developing inexpensive biomarker based tests of non-endoscopic esophagus brushings, thus: enabling cost-effective population screening to detect BE, enabling cost effective surveillance to catch early progression of BE to HGD and EAC, reducing EAC deaths, and reducing over-treatment of LGD.

Colorectal

Investigator Site
Johns Hopkins University School of Medicine
University of Pittsburgh Cancer Institute
ctDNA for the Early Detection and Monitoring of Colorectal Cancer
Project Summary

A blood test for early detection of cancer would provide a valuable, additional means for screening the population at risk. Blood-based biomarkers for...

A blood test for early detection of cancer would provide a valuable, additional means for screening the population at risk. Blood-based biomarkers for monitoring cancer could enhance care by earlier identification of subjects at risk of recurrence, better prognostic assessment, and potentially, improvements in survival or quality of life due to earlier implementation of alternative therapy. Thus, a “liquid biopsy” for early detection and for non-invasive assessment of tumor and tumor characteristics during treatment would represent a significant medical advance. Circulating tumor DNA (ctDNA) are small fragments of nucleic acid that originate from apoptotic or necrotic tumor cell turnover. Characteristic of the malignant process, ctDNA can be assessed in plasma, and offers the potential of a sensitive and specific biomarker for a host of applications including diagnosis or early detection of tumors, prognostic information on disease-free or overall survival, and predictive information on resistance and probability of lack of response to treatment. Previous ctDNA studies have been implemented by identifying characteristic mutations in the primary tumor and subsequently interrogating plasma DNA from the same patient for the presence of those mutations. The next step in evaluating ctDNA as a screening modality is to construct a panel of mutations amenable to detection in plasma (a &quot;PlasmaSeq&quot; panel) to assess the sensitivity and specificity of plasma ctDNA in identifying cancer without prior knowledge of which mutations are present in the tumor of the patient whose plasma is assayed. In Aim 1, we will prospectively recruit patients with colorectal cancer (CRC), disease-free controls, and subjects with adenomas prior to definitive surgical or endoscopic treatment and systematically evaluate a PlasmaSeq panel to explore the utility of ctDNA as a marker for early detection. Previous studies suggest that ctDNA can be used to monitor cancer in subjects under treatment or at risk for recurrent disease. In Aim 2, we will recruit newly diagnosed stage III CRC patients, determine their tumor mutational profile, and systematically collect high volume (>10 ml), serial plasma specimens every 3 months for up to 4 years for ctDNA and concurrent CEA measurement. Clinical outcome and survival will be tracked and parameters of ctDNA assessment, including absolute level, velocity of change, and degree of fluctuation will be evaluated in relation to clinical outcome, stratified by tumor stage classification (stage IIIA-IIIC). The resulting data will permit assessment of ctDNA as a prognostic marker for disease-free and overall survival. This research will further advance study on the use of ctDNA in early detection and monitoring of CRC. ctDNA testing is also applicable to many other cancers. Thus, advancement in this technology is potentially of great impact to cancer care.

Lung

Investigator Site
Wistar
Integration of Biomarker Signatures from Peripheral Blood for Diagnosis, Prognosis, Remission and Recurrence of Lung Cancer
Project Summary

The National lung Screening Trial has demonstrated that a 20% reduction in lung cancer mortality is associated with routine LDCT screening of older in...

The National lung Screening Trial has demonstrated that a 20% reduction in lung cancer mortality is associated with routine LDCT screening of older individuals with a heavy smoking history, but of the patients that had a positive screen for lung cancer based on lung nodules detected, approximately 96% proved to be false positives. These statistics highlight two unmet medical needs required to maximize the diagnostic potential of LDCT: 1) the development of diagnostic platforms that will distinguish malignant from benign nodules identified by routine LDCT, and 2) the development of inexpensive, non-invasive methods that can identify at risk individuals who would benefit from follow up with LDCT.<br><br>The proposed research in Project 1 capitalizes on technical advances for assaying gene expression and abundant prior evidence that tumors are highly interactive with the immune system. Our previous studies demonstrated that it is possible to diagnose early-stage lung cancer with 90% sensitivity and 80% specificity using gene expression signatures from PBMC. The proposed research translates the PBMC diagnostic to a more clinically viable sample collection platform with the additional goal of increasing accuracy and assessing immunological processes affected by the presence or removal of a lung tumor. We present preliminary studies that support the hypothesis that this can be done. We have enriched the signature development process by assessing both mRNA and miRNA expression profiles to assess complimentary mechanisms for regulating gene expression and will also integrate Natural Killer cell and Myeloid cell markers associated with prognosis. We also introduce in Project 2 an assay for tumor associated antigens, the cancer testis antigens (CTAs) also associated with circulating tumor cells, cancer cell derived exosomes or other potentially important cells such as cancer stem cells. We provide strong preliminary evidence that detection of the mRNA for the CTA AKAP4 in PBMC derived RNA is possible and that detection is very highly correlated with the verified presence of a lung tumor. Strong preliminary results are presented for both projects. We also propose to integrate and expand the signatures from these 2 studies and assess accuracy on a single reliable platform that can assess both mRNA and miRNA expression, and is already FDA approved for a breast cancer prognosis signature, the nCounter from Nanostring.<br>

Investigator Site
University of Hawaii
New York University School of Medicine
The EDRN Mesothelioma Biomarker Discovery Laboratory
Project Summary

Investigator Site
Johns Hopkins Whiting School of Engineering
University of Pittsburgh School of Medicine
Ultrasensitive Detection of Tumor Specific DNA Methylation Changes for the Early Detection of Lung Cancer
Project Summary

This proposal seeks to improve upon the management of lung cancer through detection of tumor specific abnormal DNA methylation. Despite highly publici...

This proposal seeks to improve upon the management of lung cancer through detection of tumor specific abnormal DNA methylation. Despite highly publicized advances in genomics and proteomics, the promise of non-invasive diagnostics and personalized medicine remains largely unrealized. Recently, comprehensive determination of genetic and epigenetic aberrations has become a major activity in cancer research since it is well understood that these aberrations provide clues to the process of tumorigenesis. The applicants have developed extremely sensitive assays for the detection of hypermethylated DNA sequences. They have also optimized the isolation and processing of circulating cell free DNA from tumors for these sensitive methods. The comprehensive genome wide analysis of molecular changes in cancer completed by The Cancer Genome Atlas (TCGA) has been used to identify many highly frequent cancer specific methylation events in lung cancer that will be combined with an integrated approach to sample processing and preparation and novel sensitive detection strategies to provide utrasensitive detection of tumor specific changes in DNA methylation in blood and sputum samples. With a large population based screening cohort, the Pittsburgh Lung Screening Study, they will develop and characterize the performance of sensitive methods for detecting cancer specific changes in DNA methylation. This molecular detection will compliment CT screening to address the important issue of early detection of lung cancer

Ovarian

Investigator Site
Johns Hopkins
Johns Hopkins University School of Medicine
Development of in vitro Diagnostic Mulitvariate Index Assay Using Liquid-based Cervical Cytology Specimen and/or Serum/Plasma Biomarkers for the Detection of Early Stage or Low-volume Ovarian Cancer
Project Summary

We have assembled a multidisciplinary team including biomarker researchers, cancer biologist, pathologist, gynecologic oncologist, proteomic technolog...

We have assembled a multidisciplinary team including biomarker researchers, cancer biologist, pathologist, gynecologic oncologist, proteomic technologists, and experts in biostatistics, epidemiology, and bioinformatics to establish a Biomarker Developmental Laboratory for the NCI’s Early Detection Research Network with the objective to develop an in vitro diagnostic multivariate index assay (IVDMIA) to detect ovarian cancer at low tumor volume. The intended use of such a test is to further enrich ovarian cancer prevalence in high-risk populations to allow for cost-effective additional workup tests. The rationale is based on 1) prognosis of ovarian cancer patients, in addition to stage/grade at diagnosis, is affected by the initial size of the metastatic disease and the size of residual disease after cytoreductive surgery; and 2) newly developed cancer-specific biomarkers detecting mutant DNAs in liquid-based cervical cytology specimens and circulating tumor DNA (ctDNA) in plasma have demonstrated a remarkable specificity. We hypothesize that combining such biomarkers with additional sensitive and disease burden-associated biomarkers in an IVDMIA will allow us to detect ovarian cancer at low volume which currently represents an unmet clinical need.

Investigator Site
University of Alabama at Birmingham
Massachusetts General Hospital
Proteomic, Genomic, and Longitudinal Pathways to Ovarian Cancer Biomarker Discovery
Project Summary

The application’s broad, long-term objectives are to discover a blood test for early detection of ovarian cancer that will reduce ovarian cancer morta...

The application’s broad, long-term objectives are to discover a blood test for early detection of ovarian cancer that will reduce ovarian cancer mortality through regular testing of targeted populations. Initially these populations would include women at high risk due to family history and/or presence of a BRCA1 or BRCA2 mutation within the family, and all postmenopausal women. This is the age group where the incidence of disease is highest. The test requires high sensitivity for early stage disease and very high specificity so that few false positive tests will occur for each true positive test.<br><br>The specific aims are 1) to discover high probability candidate biomarkers through longitudinal proteomic analysis of serial plasma obtained from screening studies of large cohorts, 3) prioritize candidate protein biomarkers for verification by change-point analysis and ranking by earliest change-point, 4) construct targeted mass spectrometric assays for the top 50 protein candidates and measure these candidates in longitudinal plasma in cases prior to clinical detection and in controls, where cases and controls are from an ovarian cancer screening trial, 4) determine which candidates have earliest sensitivity by estimating the change-point at which the candidate rises significantly above baseline, and 5) discover high probability candidate DNA mutational biomarkers from genomic analysis of cervico-vaginal fluid in women with malignant and benign pelvic masses, 6) validate DNA mutational candidates in an independent validation sample set of CVF from cases and benign controls.<br><br>Further refinement and testing of proteomic and genomic biomarkers and their combination to identify the best panel and classifier of early detection ovarian cancer biomarkers in the biorepositories of larger scale screening studies is planned but is outside the scope of this application. <br>

Pancreas

Investigator Site
Duke University
Van Andel Research Institute
The Detection and Prognosis of Early Stage Pancreatic Cancer by Interdependent Plasma Markers
Project Summary

Dr. Allen moved from Memorial Sloan Kettering to Duke in September, 2018. RM...

Dr. Allen moved from Memorial Sloan Kettering to Duke in September, 2018. RM

Prostate

Investigator Site
Eastern Virginia Medical School
The University of California, Los Angeles
Princess Margaret Cancer Centre, University Health Network, University of Toronto
Development of Protein Biomarkers in Post-DRE Urine for use in Liquid Biopsy of Prostate Cancer
Project Summary

Prostate cancer (PCa) remains the most common non-skin malignancy afflicting men in the United states. It is the second leading cause of cancer-relate...

Prostate cancer (PCa) remains the most common non-skin malignancy afflicting men in the United states. It is the second leading cause of cancer-related death. The clinical diversity of PCa is dramatic, ranging from asymptomatic disease to metastatic and fatal malignancy. One cause of this clinical diversity is the remarkable intra- and inter-tumoural heterogeneity in disease genomics. As a result, currently clinically-used risk-stratification strategies do not robustly discriminate aggressive from indolent diseases, leading to systemic over- and undertreatment. Approximately 40% of men diagnosed with PCa who seek curative treatment undergo surgical removal of their prostate (radical prostatectomy, RP). Of these, approximately 30% are found at surgery to have disease outside their prostate (non-organ-confined, non-OC). These men are candidates for multi-modal adjuvant treatment with chemo- and hormonetherapy to improve outcomes. We therefore propose to tackle this problem, using fluid biomarkers to circumvent the molecular heterogeneity of the disease. Our proposal leverages an active and productive multi-investigator, multi-institutional proteomic collaboration to develop biomarkers for the early detection of locally aggressive non-organ-confined disease. Our two lead biomarkers are 1) A multiple peptide panel that discriminates OC from non-OC in EDRN phase 2 equivalent validation (Nature Communications, in press). 2) Surface expression of CUB Domain Containing Protein 1 on exosomes differentiates PCa aggressiveness (EDRN Phase 1 equivalent discovery, Oncotarget, 2016). We propose both validation of these targets in a globally-unique biobank of expressed prostatic secretions, as well as novel biomarker discovery/development strategies to extend them in the same clinical context and sample matrix. Successful completion of our proposed studies will result in validation of at least two biomarkers for clinical utility in separation of OC vs. non-OC disease, helping to personalize therapy for a tumour type that afflicts 1 in 7 North American men.

Investigator Site
University of Michigan
University of Michigan
Discovery and Quantification of Transcriptomic Biomarkers for the Early Detection of Aggressive Prostate Cancer
Project Summary

This application proposes the formation of a University of Michigan (UM) EDRN Biomarker Development Lab (BDL). Through previous EDRN BDLs, our team ha...

This application proposes the formation of a University of Michigan (UM) EDRN Biomarker Development Lab (BDL). Through previous EDRN BDLs, our team has characterized multiple important prostate cancer biomarkers, most notably TMPRSS2-ETS gene fusions. Through collaboration with an EDRN Clinical Validation Center (CVC; Dr. Sanda PI), we have developed, validated and clinically implemented Mi-Prostate Score (MiPS), a prostate cancer early detection test incorporating urine quantification of two prostate cancer specific transcripts—the TMPRSS2:ERG gene fusion and PCA3—with serum PSA. Introduced in our CLIA laboratory (and now with New York State approval), MiPS helps shared decision making after PSA testing based on individualized risk predictions of aggressive prostate cancer on biopsy. Here, using this work as a model, we will discover and characterize aggressive prostate cancer transcriptomic biomarkers, focusing on long non-coding RNAs (lncRNAs). Although lncRNA biomarker utility has been largely unexplored, we recently characterized the lncRNA compendium (“MiTranscriptome”), identifying several prostate cancer-specific and aggressive prostate cancer-specific lncRNAs. Supporting our proposed approach, we have performed initial validation of the lncRNA SChLAP1 as an aggressive prostate cancer specific biomarker in tissues. Likewise, we have developed RT-PCR based next generation sequencing (NGS) panels capable of quantifying multiplexed transcriptomic biomarkers in archived tissue and urine. Here, in three Aims, we will nominate and develop transcriptomic biomarkers as predictors of aggressive prostate cancer both at and prior to diagnosis. In Aim 1, we will identify novel aggressive prostate cancer-associated transcriptomic alterations from our MiTranscriptome analysis. We will develop single gene and multiplexed NGS assays to study these lncRNAs/coding transcripts as aggressive prostate cancers specific biomarkers. In Aim 2 we will characterize transcripts from Aim 1 as tissue based aggressive prostate cancer biomarkers. Following our previous approach with SChLAP1, we will develop individual in situ hybridization assays and a multiplexed NGS panel to characterize these transcripts in well characterized prostate cancer tissue cohorts. In Aim 3, we will characterize transcripts identified in Aim 1 as non-invasive, urine-based aggressive prostate cancer early detection biomarkers. Through collaboration with Hologic/Gen-Probe (our industry partner on MiPS), we will develop and assesses the performance of individual prioritized biomarkers using their platform on our biobanked urine samples. Additionally, using multiplexed NGS, we will also characterize the performance of a panel of transcriptomic biomarkers as an alternative/complementary approach. As recognized by the EDRN, novel aggressive prostate cancer specific biomarkers are urgently needed. Importantly, our approach extends beyond prostate cancer and our BDL, and our group has actively participated in the EDRN biomarker community and anticipates continuing work with other BDLs and CVCs to facilitate the overall EDRN mission.

Investigator Site
Johns Hopkins University School of Medicine
Institute for Molecular Systems Biology
Glycoprotein Biomarkers for Early Detection of Aggressive Prostate Cancer
Project Summary

Prostate cancer is the most prevalent type of cancer and it is the second highest contributor to cancer death among men in the U.S. A major issue in p...

Prostate cancer is the most prevalent type of cancer and it is the second highest contributor to cancer death among men in the U.S. A major issue in prostate cancer detection and therapy is that we currently have no method to reliably distinguish aggressive prostate cancer from non-aggressive prostate cancer. This leads to significant unnecessary suffering among prostate cancer patients. We hypothesize that specific glycoproteins or their glycosylation specifically altered in aggressive prostate cancer cells can be used as biomarkers to distinguish patients with aggressive from those with non-aggressive prostate cancer. We propose in four specific aims to develop novel glycoprotein biomarkers that can detect aggressive cancer in pre-surgical urine or biopsy tissues. In Aim 1, we will analyze urinary glycoproteins from patients with aggressive cancer and non-aggressive cancer using high throughput glycoproteomics and mass spectrometry to identify glycoproteins associated with aggressive prostate cancer. In Aim 2, we will validate the identified candidate urinary glycoproteins by targeted analysis of candidate glycoproteins from additional urine samples in independent testing sets of prostate cancer urine specimens from the EDRN network. In Aim 3, we will develop highly sensitive, specific, and high throughput ELISA or mass spectrometry based selective reaction monitoring assays as noninvasive urine tests using the glycoprotein biomarkers identified and validated from Aim 1 and Aim 2 and validate the performance of the tests for aggressive prostate cancer biomarkers. We will further determine the clinical utility of the validated tests to detect patients with aggressive prostate cancer in active surveillance program. In Aim 4, we will develop and optimize the immunohistochemistry assays for the glycoproteins associated aggressive prostate cancer tissues and validate these tissue glycoproteins using tissue microarrays. We will then further determine the clinical utility of the immunohistochemistry assays as biopsy based tissue tests for the early detection of patients with aggressive prostate cancer in active surveillance program. If successful, the identified and validated biomarkers will be tested by EDRN biomarker reference laboratory (BRL) and clinical validation center (CVC) in retrospective and prospective studies. Biomarkers capable of distinguishing aggressive from nonaggressive prostate cancer will allow men with aggressive prostate cancer to receive appropriate treatment earlier in the course of their diseases and prevent men with nonaggressive prostate cancer from overtreatment.

Biomarker Reference Laboratories

Site Investigator Organ
Johns Hopkins Medical Institutions Prostate

This proposal is a renewal of our EDRN Biomarker Reference Laboratory (BRL) which is located within the Clinical Chemistry Division (CCD) of the Johns...

This proposal is a renewal of our EDRN Biomarker Reference Laboratory (BRL) which is located within the Clinical Chemistry Division (CCD) of the Johns Hopkins Medical Laboratories (JHML) at the Johns Hopkins Hospital. The BRL will continue to serve as a network resource for clinical and laboratory validation of biomarkers, which includes technological development and assay refinement. The JHML are certified by the College of American Pathologist (CAP) and regulated by CLIA (Clinical Laboratory Improvement Amendments of 1988). As such, the JHML follow stringent, good laboratory practice (GLP) guidelines for quality control and quality assurance. The proposed product development will be conducted at the Center for Biomarker Discovery and Translation (CBDT) at The Johns Hopkins University. The project goal is to validate serum proteomic biomarkers, including two biomarkers discovered in our current EDRN BRL developmental study, for the prediction of aggressive prostate cancer in men prior to prostate biopsy. The product “AGPC” is an in vitro diagnostic multivariate index assay (IVDMIA) that combines a panel of biomarkers into a single-valued numerical index score. We have assembled a strong team of research and clinical scientists with many years of experience with cancer biomarkers and in technology development, study design, bioinformatics, validation, and translation. Dr. Chan, the PI, is the Director of both CCD and CBDT. He has over 30 years of experience in clinical chemistry and has conducted many (> 75) research studies funded by industry on cancer diagnostics leading to the approval by the FDA. Since the inception of the EDRN in 2000, five EDRN developed assays have been approved by the FDA for clinical use. Of these five, our BRL led the development of serum OVA1 for ovarian cancer, serum proPSA (phi) for prostate cancer, and served as the reference lab for the urine PCA3 study for prostate cancer. In fact, OVA1 which is based on our original multiplex proteomic study published in Cancer Research, was the first proteomic IVDMIA ever cleared by the FDA for clinical use. In addition, three leading diagnostics/biotechnology companies have agreed to collaborate with us in our product development proposal. In this renewal, we plan to continue our strong commitment to the EDRN mission through network collaborations, and provide leadership in biomarker validation, technology/assay improvement, and product development. With this multi-disciplinary team of scientists, the BRL at Johns Hopkins offers the best opportunity for the success of cancer biomarker validation and translation into the clinic for the early detection of cancer.
Pacific Northwest National Laboratory Ovary
National Institute of Standards & Technology Lung
Center for Prostate Disease Research Uniformed Services University of the Health Sciences and the Walter Reed National Military Medical Center Prostate
University of Maryland School of Medicine Bladder, Colon, Esophagus, Lung

This is a renewal application for the University of Maryland Baltimore Biomarker Reference Laboratory (UMB BRL). Over the past 5 years the UMB BRL (PI...

This is a renewal application for the University of Maryland Baltimore Biomarker Reference Laboratory (UMB BRL). Over the past 5 years the UMB BRL (PI, Sanford Stass, MD) have been active collaborating and supporting the Early Detection Research Network (EDRN). The PI participated on multiple EDRN committees/activities. The UMB BRL has provided resources for analytical and clinical validation of biomarkers, assay development/technologies, and standardization of assay methods in collaboration with multiple investigators. The UMB BRL is organized as a team of directors/co-investigators with broad EDRN knowledge, experience, expertise and provides a wide range of core pathology laboratories with CLIA and/or CAP accreditation including next generation sequencing, clinical chemistry, molecular diagnostics, flow cytometry, cytogenetics, and GLP compliant laboratories. There are also core laboratories including genomics, mass spectrometry, NMR tissue bank, and biostatistics. There is a product development study, with the objective to develop targeted next generation sequencing (NGS) using Ion Torrent (ITO) for miRNAs biomarkers (developed here) in sputum obtained with the Lung Flute (LF) for the early detection of non-small-cell lung cancer in patients with nodules on CT scan. There are 3 specific aims: (1) To validate whether the 102 miRNA biomarker candidates of lung cancer we recently identified, which include 2 miRNAs from our previous EDRN study, can be analyzed in lung tumor samples by using the IoT-targeted NGS platform in a CLIA accredited laboratory. (2) To optimize a panel of highly specific and sensitive sputum miRNA biomarkers for identifying malignant pulmonary nodules using our retrospective sputum specimens with the IoT platform. (3) To validate analytical and clinical performance of the biomarker panel using the IoT in prospectively collected sputum samples from the University of Maryland, Vanderbilt-Ingram Cancer Center, and the New York University Langone Medical Center using the Lung Flute. The UMB BRL leverages the experience of its multi-disciplinary investigators and considerable expertise of the leadership to provide flexible support to the EDRN for standardized procedures, high throughput, robust assays, clinical translation, design and conduct analytical validation studies, a variety of laboratory/platform assays, GLP compliance, and adherence to regulatory requirements including CLIA/CAP, FDA, and GLP. Numerous collaborations are within and outside UMB guaranteeing maximum responsiveness to the EDRN. Lines of authority/organizational structure in the UMB BRL ensure timely performance, efficient communication and rapid translation of findings from the development phase into clinical application.

Clinical Validation Centers

Site Investigator Organ
The University of Texas MD Anderson Cancer Center Ovary

Advances in cytoreductive surgery and combination chemotherapy have improved 5-year survival in patients with epithelial ovarian cancer, but the rate ...

Advances in cytoreductive surgery and combination chemotherapy have improved 5-year survival in patients with epithelial ovarian cancer, but the rate of cure remains essentially unchanged over the last two decades. Computer models suggest that detection of ovarian cancer in early stage (I-II) could improve rates of cure by 10-30%. Sequential use of serum biomarkers measured over time followed by TVS in a small fraction of postmenopausal women with rising CA125 has proven more specific and more sensitive than either modality used alone. Using this strategy, the United Kingdom Collaborative Trial for Ovarian Cancer Screening (UKCTOCS) and the Normal Risk Ovarian Cancer Screening Study (NROSS) in the United States have shown that only 3 operations are required to detect each case of ovarian cancer. Over the last 13 years, our group has conducted the NROSS study in 4,904 postmenopausal women at average risk for ovarian cancer. Annual determinations of CA125 have been analyzed by the Risk of Ovarian Cancer Algorithm (ROCA) developed by Dr. Skates. If the risk does not change, women return in a year; if it increases markedly, TVS is performed and participants are referred to a gynecologic oncologist; if the risk is intermediate CA125 is repeated in 3 months. Fifteen operations have been performed to detect 10 ovarian cancers. Two were borderline tumors and 8 were invasive with 8 of the 10 (80%) in Stage I or II. The NROSS trial has utilized a well-coordinated network of 7 sites in the United States where 22,981 blood samples have been obtained, processed and stored with standard operating protocols. Pre-operative specimens from MDACC have been banked from 502 women with ovarian cancer and 737 with benign disease. This has provided a valuable resource for evaluating new biomarkers. As CA125 is expressed by only 80% of epithelial ovarian cancers, additional biomarkers will be required to optimize sensitivity. Our group has found that HE4 and CA72.4 can detect 16% of the cases missed by CA125 in samples from the UKCTOCS trial. Autoantibodies to tumor associated antigens have shown even greater promise. Elevated levels of autoantibodies against TP53 have been found in 20-25% of patients with normal CA125 at the time of conventional diagnosis. Titers of anti-TP53 rise 13.5 months (mean) prior to CA125 and 33 months (mean) prior to diagnosis in patients who present without an increase in CA125. At present we are developing a new ROCA that incorporates CA125, HE4, CA72.4 and anti-TP53 autoantibody data. A multidisciplinary team of 27 investigators will pursue the following Specific Aims: 1) to conduct a screening trial to determine the specificity and positive predictive value for a 4 biomarker ROCA including CA125, HE4, CA72.4 and anti-TP53 autoantibodies in a two stage strategy for early detection of ovarian cancer in postmenopausal women at average risk for the disease; 2) to maintain and share a serum and plasma bank to facilitate evaluation of novel biomarkers for early detection; 3) to collaborate with other Centers in the EDRN to evaluate additional biomarkers for early detection of ovarian cancer.
University of Nebraska Medical Center Pancreas

A majority of pancreatic cancer (PC) patients (> 80%) present with an unresectable primary tumor with distant metastasis at the time of diagnosis due ...

A majority of pancreatic cancer (PC) patients (> 80%) present with an unresectable primary tumor with distant metastasis at the time of diagnosis due to its asymptomatic nature and lack of methods for early detection. While the overall 5-year survival rate of PC is dismal, significantly better outcomes have been reported for early stage smaller tumors. PC is believed to progress through a series of histological changes and recent estimates indicate that these changes require 15-20 years to develop into invasive metastatic disease, hence providing a window of opportunity to intervene. While early diagnosis is an obvious strategy to improve the survival of PC patients, lack of non-invasive biomarkers for risk prediction of precursor lesions or early stage invasive disease impedes our ability to diagnose PC during this “window. Premalignant cystic lesions of the pancreas offer unique opportunity for early diagnosis. To meet the EDRN stated goal of performing a validation study for early cancer detection and risk assessment likely to yield meaningful results within 5 years, we propose an innovative approach that could lead to the development of a clinically useful biomarker in this time frame. Additionally, we propose to study cystic neoplasms since IPMN and MCN offer a unique opportunity to identify pancreatic premalignant lesions and serve as a target for early detection strategies. The candidate biomarkers studies in our application have been identified and evaluated over the past 5 years in EDRN-funded biomarker developmental laboratories (BDLs). Studies from the laboratories of participating investigators have conclusively established that mucin overexpression is a hallmark of pancreatic cancer and have identified biomarkers (MUC5AC and its 2 glycoforms, MUC4 and a glycoform of endorepellin) that can effectively distinguish a) patients with resectable PC patients from patients with benign pancreatic diseases; b) mucinous and nonmucinous cysts; c) high-grade from moderate- and low-grade mucinous cysts and d). high-risk intestinal type IPMNs and low risk gastric type IPMNs. The overall objective of this CVC proposal is to demonstrate the ability of the aforementioned biomarkers to distinguish pancreatic adenocarcinoma (PC) patients from healthy controls, patients with benign biliary obstruction and chronic pancreatitis (CP), and to identify those cysts with high malignant potential. We have a large number of high quality, well-characterized specimens from patients with pancreatic disease and diseased controls that were collected and processed following protocols developed through the EDRN. Two specific aims are proposed. Aim 1 will use available samples from our biospecimen repository to evaluate MUC5AC and MUC4 as biomarkers to distinguish pancreatic adenocarcinoma (PC) patients from healthy controls, and from patients with benign biliary obstruction and chronic pancreatitis (CP). Aim 2 will determine if our biomarkers can identify those cysts with high lethal potential from those with a low risk for malignant transformation.
University of Pittsburgh Pancreas

A majority of pancreatic cancer (PC) patients (> 80%) present with an unresectable primary tumor with distant metastasis at the time of diagnosis due ...

A majority of pancreatic cancer (PC) patients (> 80%) present with an unresectable primary tumor with distant metastasis at the time of diagnosis due to its asymptomatic nature and lack of methods for early detection. While the overall 5-year survival rate of PC is dismal, significantly better outcomes have been reported for early stage smaller tumors. PC is believed to progress through a series of histological changes and recent estimates indicate that these changes require 15-20 years to develop into invasive metastatic disease, hence providing a window of opportunity to intervene. While early diagnosis is an obvious strategy to improve the survival of PC patients, lack of non-invasive biomarkers for risk prediction of precursor lesions or early stage invasive disease impedes our ability to diagnose PC during this “window. Premalignant cystic lesions of the pancreas offer unique opportunity for early diagnosis. To meet the EDRN stated goal of performing a validation study for early cancer detection and risk assessment likely to yield meaningful results within 5 years, we propose an innovative approach that could lead to the development of a clinically useful biomarker in this time frame. Additionally, we propose to study cystic neoplasms since IPMN and MCN offer a unique opportunity to identify pancreatic premalignant lesions and serve as a target for early detection strategies. The candidate biomarkers studies in our application have been identified and evaluated over the past 5 years in EDRN-funded biomarker developmental laboratories (BDLs). Studies from the laboratories of participating investigators have conclusively established that mucin overexpression is a hallmark of pancreatic cancer and have identified biomarkers (MUC5AC and its 2 glycoforms, MUC4 and a glycoform of endorepellin) that can effectively distinguish a) patients with resectable PC patients from patients with benign pancreatic diseases; b) mucinous and nonmucinous cysts; c) high-grade from moderate- and low-grade mucinous cysts and d). high-risk intestinal type IPMNs and low risk gastric type IPMNs. The overall objective of this CVC proposal is to demonstrate the ability of the aforementioned biomarkers to distinguish pancreatic adenocarcinoma (PC) patients from healthy controls, patients with benign biliary obstruction and chronic pancreatitis (CP), and to identify those cysts with high malignant potential. We have a large number of high quality, well-characterized specimens from patients with pancreatic disease and diseased controls that were collected and processed following protocols developed through the EDRN. Two specific aims are proposed. Aim 1 will use available samples from our biospecimen repository to evaluate MUC5AC and MUC4 as biomarkers to distinguish pancreatic adenocarcinoma (PC) patients from healthy controls, and from patients with benign biliary obstruction and chronic pancreatitis (CP). Aim 2 will determine if our biomarkers can identify those cysts with high lethal potential from those with a low risk for malignant transformation.
University of Michigan Colorectal

Continued support of the Great Lakes New England (GLNE) Clinical Validation Center (CVC) of the Early Detection Research Network (EDRN) via the U01 me...

Continued support of the Great Lakes New England (GLNE) Clinical Validation Center (CVC) of the Early Detection Research Network (EDRN) via the U01 mechanism is requested. The GLNE CVC is a highly collaborative, multi-institutional consortium designed to develop, implement and analyze trials for the validation of biomarkers for the early detection of colorectal adenocarcinoma and other GI malignancies. Over the last 15 years, the GLNE has: 1. developed a high quality repository of samples collected from human subjects with colorectal, lower esophageal neoplasias, pancreatic neoplasms and controls; 2. collaborated with 9 biomarker developmental laboratories, 4 biomarker reference laboratories, the EDRN DMCC, and 9 industrial partners publishing 36 collaborative manuscripts; 3. Performed phase I validation trials of 26 biomarkers for the early detection of colorectal adenocarcinoma; 4. Initiated and recruited 5,154 participants to a Network-wide cross sectional validation trial of biomarkers for the early detection of colorectal cancer. The GLNE proposes to 1. Complete an ongoing prospective Phase 2 validation trial of vimentin methylation, serum galectin-3 ligand, BCAT1/IKZF1 methylation in plasma, fecal immunochemical tests (FIT), Exact Sciences stool DNA panel, or any future individual biomarker individually and as a panel for the early detection of colorectal neoplasia using colonoscopy as the gold standard; 2. To perform phase 1 validation trials (training and test set designs) of promising biomarkers discovered by EDRN Biomarker Validation Laboratories, external academic collaborating institutions, and collaborating EDRN industrial partners for the early detection of colorectal cancer, high grade colorectal dysplasia, and screen relevant colorectal neoplasms; 3. Assess the frequency of missed or occult colonic and upper gastrointestinal neoplasia in patients with initially normal colonoscopies and persistently positive stool DNA testing; and 4. Continue to expand and renew the archive of appropriately preserved stool, serum, plasma, urine, tissue and DNA biospecimens to be used by EDRN investigators for future validation and biomarker discovery research. These aims will be addressed by a multi-institutional consortium of university and community GI practices recruiting human subjects undergoing screening colonoscopy under a PRoBE compliant protocol. The data will be managed and analyzed by the EDRN data management and coordinating center.
Fred Hutchinson Cancer Research Center Breast cancer (female), Ovary

There remain clear clinical and public health needs to improve the early detection of breast, colorectal, and ovary cancers. For breast and colorectal...

There remain clear clinical and public health needs to improve the early detection of breast, colorectal, and ovary cancers. For breast and colorectal cancers effective, widely used screening tests exist, but for breast cancer there remain issues with respect to optimizing mammography’s use and performance, and for colorectal cancer both limited access to and the invasiveness of colonoscopy are barriers to its wider use. Ovary cancer is less common but highly lethal, and no clinically useful tests for its early detection are currently available. Through the current breast and ovary cancer EDRN Clinical Validation Center (CVC) led by Dr. Li and the current colorectal cancer EDRN Biomarker Development Laboratory (BDL) led by Dr. Lampe, we have discovered and validated promising sets of candidate early detection biomarkers for each of these three cancers that now warrant further Phase 2 and Phase 3 validation. We propose the following three projects: Project 1: Phase 3 validation of early detection biomarkers for ER+ breast cancer: Nine candidate biomarkers that have been preliminarily validated in preclinical samples will be assessed in an independent set of preclinical samples. Their intended clinical applications are to: 1. Inform timing of a subsequent mammogram in women with a negative screening mammogram; 2. Inform continuation of mammographic screening among women 75-79 years; 3. Prioritize women who should be screened with mammography in areas with limited resources. Project 2: Phase 3 validation of early detection biomarkers for colorectal cancer: We will validate five biomarkers that have been preliminarily validated in multiple sets of samples with performance that meets or exceeds those of existing fecal tests. Our intended clinical applications are to: 1. Identify people unwilling to undergo or with no access to colonoscopy who should be prioritized for colonoscopy (improve/replace existing FIT and Cologuard tests); 2. Among symptomatic patients identify those who have a very low risk of cancer and can avoid colonoscopy. Project 3: Phase 2 and 3 validation of autoantibodies (AAb) as early detection biomarkers for serous ovarian cancer (SOC): Our overall goal is to combine novel AAb markers with currently available tests in a two-stage screening strategy with the potential to reduce ovarian cancer mortality. Our intended clinical applications are: 1. Use AAbs in conjunction with CA125 as a first line screening test; 2. Use AAbs in conjunction with HE4 for cancer early detection in women with rising CA125. In addition, we will serve as an EDRN collaborative resource providing biospecimens and expertise to support high quality PRoBE compliant EDRN discovery and validation studies across cancer types. With the combined expertise of our multidisciplinary team of investigators, this CVC will both lead welljustified, rigorously designed validation studies and provide abundant resources to EDRN. Given the strength of our biomarker candidates, the sets of biospecimens that will be used, the study designs employed, and the clearly delineated clinical applications proposed, we anticipate that this work will yield near-term clinical impact.
H. Lee Moffitt Cancer Center and Research Institute Breast cancer (female), Lung

We propose to establish the Moffitt Imaging Biomarker Validation Center (MIBVAC) focused on imaging biomarker validations for early cancer detection a...

We propose to establish the Moffitt Imaging Biomarker Validation Center (MIBVAC) focused on imaging biomarker validations for early cancer detection and accurate risk assessments by leveraging our team of strong experts, resources, planned imaging biomarker validation studies, and analysis and network collaboration structures. In previous studies we have demonstrated that various measurements from breast images quantify breast cancer risk. The large cooperative National Lung Screening Trial (NLST) also showed a significant survival improvement for individuals screened by low dose CT compared to those screened with conventional radiography. Additionally, we have recently shown that CT image analysis (radiomics) can improve classification in this data set. However, due to difficulties in obtaining accurate and reproducible measurements and high false-positive rates of current imaging, cancer imaging biomarkers have not been routinely incorporated into clinical risk assessment. If these imaging biomarkers can be accurately tailored at the individual level, their impact will be significantly improved for early cancer detection and intervention. MIBVAC plans to achieve this challenging yet quite achievable goal by rigorously evaluating and validating these imaging biomarkers for rapid translation into clinical and practical applications. We have four specific aims: (Aim 1) Establish breast imaging resources for EDRN both with our existing and new case-control datasets of breast images and to evaluate and validate breast imaging biomarkers based on newly-established case-control dataset of digital breast tomosynthesis (TS) images, (Aim 2) Evaluate and validate lung imaging biomarkers for early detection of cancer first based on NLST low-dose CT (LDCT) cohorts and then expanding with a newly-established case-control cohort of higher resolution LDCT, (Aim 3) Conduct validation studies with imaging biomarkers for EDRN partners and others for other malignancies, and (Aim 4) Refine and validate imaging biomarkers analytically for early detection of breast, lung, and other cancers and to construct MIBVAC imaging data and specimen resources for EDRN collaborations and sharing.
H. Lee Moffitt Cancer Center and Research Institute Inc. Breast cancer (female), Lung

We propose to establish the Moffitt Imaging Biomarker Validation Center (MIBVAC) focused on imaging biomarker validations for early cancer detection a...

We propose to establish the Moffitt Imaging Biomarker Validation Center (MIBVAC) focused on imaging biomarker validations for early cancer detection and accurate risk assessments by leveraging our team of strong experts, resources, planned imaging biomarker validation studies, and analysis and network collaboration structures. In previous studies we have demonstrated that various measurements from breast images quantify breast cancer risk. The large cooperative National Lung Screening Trial (NLST) also showed a significant survival improvement for individuals screened by low dose CT compared to those screened with conventional radiography. Additionally, we have recently shown that CT image analysis (radiomics) can improve classification in this data set. However, due to difficulties in obtaining accurate and reproducible measurements and high false-positive rates of current imaging, cancer imaging biomarkers have not been routinely incorporated into clinical risk assessment. If these imaging biomarkers can be accurately tailored at the individual level, their impact will be significantly improved for early cancer detection and intervention. MIBVAC plans to achieve this challenging yet quite achievable goal by rigorously evaluating and validating these imaging biomarkers for rapid translation into clinical and practical applications. We have four specific aims: (Aim 1) Establish breast imaging resources for EDRN both with our existing and new case-control datasets of breast images and to evaluate and validate breast imaging biomarkers based on newly-established case-control dataset of digital breast tomosynthesis (TS) images, (Aim 2) Evaluate and validate lung imaging biomarkers for early detection of cancer first based on NLST low-dose CT (LDCT) cohorts and then expanding with a newly-established case-control cohort of higher resolution LDCT, (Aim 3) Conduct validation studies with imaging biomarkers for EDRN partners and others for other malignancies, and (Aim 4) Refine and validate imaging biomarkers analytically for early detection of breast, lung, and other cancers and to construct MIBVAC imaging data and specimen resources for EDRN collaborations and sharing.
Fred Hutchinson Cancer Research Center Colorectal

There remain clear clinical and public health needs to improve the early detection of breast, colorectal, and ovary cancers. For breast and colorectal...

There remain clear clinical and public health needs to improve the early detection of breast, colorectal, and ovary cancers. For breast and colorectal cancers effective, widely used screening tests exist, but for breast cancer there remain issues with respect to optimizing mammography’s use and performance, and for colorectal cancer both limited access to and the invasiveness of colonoscopy are barriers to its wider use. Ovary cancer is less common but highly lethal, and no clinically useful tests for its early detection are currently available. Through the current breast and ovary cancer EDRN Clinical Validation Center (CVC) led by Dr. Li and the current colorectal cancer EDRN Biomarker Development Laboratory (BDL) led by Dr. Lampe, we have discovered and validated promising sets of candidate early detection biomarkers for each of these three cancers that now warrant further Phase 2 and Phase 3 validation. We propose the following three projects: Project 1: Phase 3 validation of early detection biomarkers for ER+ breast cancer: Nine candidate biomarkers that have been preliminarily validated in preclinical samples will be assessed in an independent set of preclinical samples. Their intended clinical applications are to: 1. Inform timing of a subsequent mammogram in women with a negative screening mammogram; 2. Inform continuation of mammographic screening among women 75-79 years; 3. Prioritize women who should be screened with mammography in areas with limited resources. Project 2: Phase 3 validation of early detection biomarkers for colorectal cancer: We will validate five biomarkers that have been preliminarily validated in multiple sets of samples with performance that meets or exceeds those of existing fecal tests. Our intended clinical applications are to: 1. Identify people unwilling to undergo or with no access to colonoscopy who should be prioritized for colonoscopy (improve/replace existing FIT and Cologuard tests); 2. Among symptomatic patients identify those who have a very low risk of cancer and can avoid colonoscopy. Project 3: Phase 2 and 3 validation of autoantibodies (AAb) as early detection biomarkers for serous ovarian cancer (SOC): Our overall goal is to combine novel AAb markers with currently available tests in a two-stage screening strategy with the potential to reduce ovarian cancer mortality. Our intended clinical applications are: 1. Use AAbs in conjunction with CA125 as a first line screening test; 2. Use AAbs in conjunction with HE4 for cancer early detection in women with rising CA125. In addition, we will serve as an EDRN collaborative resource providing biospecimens and expertise to support high quality PRoBE compliant EDRN discovery and validation studies across cancer types. With the combined expertise of our multidisciplinary team of investigators, this CVC will both lead welljustified, rigorously designed validation studies and provide abundant resources to EDRN. Given the strength of our biomarker candidates, the sets of biospecimens that will be used, the study designs employed, and the clearly delineated clinical applications proposed, we anticipate that this work will yield near-term clinical impact.
University of Texas Health Science Center at San Antonio Prostate

The San Antonio center for Biomarkers Of Risk of prostate cancer (SABOR) is a population-based, minority and underserved-enriched, cohort study that c...

The San Antonio center for Biomarkers Of Risk of prostate cancer (SABOR) is a population-based, minority and underserved-enriched, cohort study that collects extensive clinical data and biospecimens while tracking cancer-related outcomes, designed to discover, develop, and validate biomarkers of prostate cancer risk. To date, 3,142 men have been enrolled over approximately 3 years of accrual including 51% Hispanic or African American subjects. The efforts of SABOR as a CEVC have led to identifying several factors that affect prostate cancer risk including a number of genetic variations (CAG repeat length in the genes for the androgen receptor, Semaphorins 3B and 3F, SRD5A2, and variations of the Vitamin D receptor) and body mass index (higher values associated with lower levels of PSA). We have also found substantial differences in risk factors for prostate cancer in different ethnic groups (caloric intake, fat intake, micronutrient intake, body mass index, fruit and vegetable intake), as well as different performance characteristics of PSA and DRE in these ethnic/racial groups. For the second EDRN funding period SABOR will: <br><br>•<br>Continue to enroll subjects to complete recruitment of 9,000 men to the cohort, explore further these behavioral, constitutional, and somatic risk factors, develop and validate a multivariable prostate cancer risk algorithm, <br><br><br>•<br>Conduct EDRN validation studies. The SABOR scientific personnel will continue to serve in their leadership positions within the Network, assisting the EDRN with the design, conduct, and analysis of early detection validation studies that will alter the standard of care of clinical practice in the United States. <br>
Fred Hutchinson Cancer Research Center Breast and Ovarian

There remain clear clinical and public health needs to improve the early detection of breast, colorectal, and ovary cancers. For breast and colorectal...

There remain clear clinical and public health needs to improve the early detection of breast, colorectal, and ovary cancers. For breast and colorectal cancers effective, widely used screening tests exist, but for breast cancer there remain issues with respect to optimizing mammography’s use and performance, and for colorectal cancer both limited access to and the invasiveness of colonoscopy are barriers to its wider use. Ovary cancer is less common but highly lethal, and no clinically useful tests for its early detection are currently available. Through the current breast and ovary cancer EDRN Clinical Validation Center (CVC) led by Dr. Li and the current colorectal cancer EDRN Biomarker Development Laboratory (BDL) led by Dr. Lampe, we have discovered and validated promising sets of candidate early detection biomarkers for each of these three cancers that now warrant further Phase 2 and Phase 3 validation. We propose the following three projects: Project 1: Phase 3 validation of early detection biomarkers for ER+ breast cancer: Nine candidate biomarkers that have been preliminarily validated in preclinical samples will be assessed in an independent set of preclinical samples. Their intended clinical applications are to: 1. Inform timing of a subsequent mammogram in women with a negative screening mammogram; 2. Inform continuation of mammographic screening among women 75-79 years; 3. Prioritize women who should be screened with mammography in areas with limited resources. Project 2: Phase 3 validation of early detection biomarkers for colorectal cancer: We will validate five biomarkers that have been preliminarily validated in multiple sets of samples with performance that meets or exceeds those of existing fecal tests. Our intended clinical applications are to: 1. Identify people unwilling to undergo or with no access to colonoscopy who should be prioritized for colonoscopy (improve/replace existing FIT and Cologuard tests); 2. Among symptomatic patients identify those who have a very low risk of cancer and can avoid colonoscopy. Project 3: Phase 2 and 3 validation of autoantibodies (AAb) as early detection biomarkers for serous ovarian cancer (SOC): Our overall goal is to combine novel AAb markers with currently available tests in a two-stage screening strategy with the potential to reduce ovarian cancer mortality. Our intended clinical applications are: 1. Use AAbs in conjunction with CA125 as a first line screening test; 2. Use AAbs in conjunction with HE4 for cancer early detection in women with rising CA125. In addition, we will serve as an EDRN collaborative resource providing biospecimens and expertise to support high quality PRoBE compliant EDRN discovery and validation studies across cancer types. With the combined expertise of our multidisciplinary team of investigators, this CVC will both lead welljustified, rigorously designed validation studies and provide abundant resources to EDRN. Given the strength of our biomarker candidates, the sets of biospecimens that will be used, the study designs employed, and the clearly delineated clinical applications proposed, we anticipate that this work will yield near-term clinical impact.
The University of Texas M D Anderson Cancer Center Pancreas

Early detection of PDAC is an area of highest priority and an unmet need for advancing public health in the United States. Certain sub-groups of patie...

Early detection of PDAC is an area of highest priority and an unmet need for advancing public health in the United States. Certain sub-groups of patients, such as those with mucinous pancreatic cysts are at higher risk for progression to PDAC, but even in these cohorts, there is potential for over-diagnosis, underscoring the need for biomarkers that can accurately distinguish aggressive versus indolent cysts. The long term goal of our EDRN Clinical Validation Center (CVC), comprised of MD Anderson (MDACC), University of Utah and Indiana University, is to implement a multi-institutional framework for collecting the highest quality biospecimens from patients with a variety of well-defined pancreatic pathologies in order to conduct biomarker validation studies for early detection of PDAC that conform to EDRN-defined Phase 2 and Phase 3 study design. Specifically, this CVC will prospectively recruit at least 600 patients with early stage (resected) PDAC, at least 300 patients with surgically resected pancreatic cystic lesions of varying histology and grades of dysplasia, at least 400 benign pancreatic diseases (including chronic pancreatitis, benign cysts, endocrine tumors of low malignant potential), at least 300 patients with non-resected pancreatic cystic lesions that have follow up of 2 years or greater without evidence for progression, and at least 300 control patients with nonpancreatic diseases, in order to obtain plasma and serum samples from these subjects for biomarker validation studies. Additionally, we will obtain cyst fluid samples from all patients with pancreatic cystic lesions, both surgically resected and those being followed by endoscopic imaging. In accordance with the EDRN principles, these biospecimens will be utilized in facilitating collaborations with other BDLs, for biomarker discovery and validation studies. Preliminary data generated in our CVC has identified a focused panel of overexpressed autoantibodies and antigens (ERBB2, TNC, ESR1, CACNA1D and CDKN2AIP) that significantly improves CA19-9 AUC in both diagnostic and pre-diagnostic cohorts. We will use a hybrid array platform developed at Fred Hutchinson Cancer Research Center (FHCRC) that is capable of quantifying both antigens and autoantibodies from plasma, and use this platform to complete three PRoBE compliant biomarker studies: Study 1 will be an EDRN-defined Phase 3 study in pre-diagnostic PDAC samples (n=158) and matched controls (n=158) from WHI and PLCO cohorts, followed by an EDRN-defined Phase 2 case control study of early stage (resectable) PDAC (N = 300) versus chronic pancreatitis (N = 300) and non-pancreatic disease controls (N=300); Study 2 will be an EDRN-defined Phase 3 study in PLCO pre-diagnostic PDAC samples (n=160), and matched controls (n=160); and Study 3 will be an EDRN-defined Phase 2 case control study of pancreatic cystic neoplasms with high-grade dysplasia or cancer (N =150) versus pancreatic cystic neoplasms with surgically confirmed low-grade dysplasia and non-mucinous cystic lesions (N=150), as well as low-risk cyst with adequate follow up that are followed without surgery (N=150).
Vanderbilt -Ingram Cancer Center Lung

This multidisciplinary effort of experts in biomarker research proposes to renew their commitment to the EDRN and to lead our Clinical Validation Cent...

This multidisciplinary effort of experts in biomarker research proposes to renew their commitment to the EDRN and to lead our Clinical Validation Center ever closer to impacting patient care. Therefore we propose to test best candidate biomarkers of lung cancer developed at our and other institutions for added value in the assessment of the risk for, and diagnosis of, lung cancer compared to the standard of care. The hypothesis is that addition of imaging and molecular biomarkers measured by chest computed tomography and in the sputum, the bronchial epithelium and blood, likely in a multivariable manner, could improve the identification of high risk individuals for lung cancer and improve CT screening overall results by reducing false-positive tests. We propose a three way approach. First we will test candidate biomarkers for lung cancer development in an observational study of selected very high risk individuals from the Nashville community performing repeated measurements of clinical, imaging (low-dose chest CT) variables, as well as molecular biomarker signatures, some of which will be obtained from bronchoscopy. Second, we propose to validate the most promising diagnostic candidate signatures to each test in carefully designed prospective study of individuals presenting with indeterminate pulmonary nodules. Third, we will test a novel molecular imaging tracer in a population of intermediate and high risk lung nodules. This tracer will be compared to standard of care FDG PET, and if significantly better, should have huge impact on the management of lung nodules. Our CVC will also centralize an effort to collect and store pertinent clinical data and tissues (blood, urine, and the airways specimens) and make these resources available to the community and to collaborators within and outside of the EDRN program, including the industry partners.
Emory University Bladder, Breast cancer (female), Ovary, Prostate

We hypothesize that early detection, targeting aggressive prostate cancer, will enable survival benefits of treatment for lethal disease, and reduce h...

We hypothesize that early detection, targeting aggressive prostate cancer, will enable survival benefits of treatment for lethal disease, and reduce harms of over-treatment for indolent disease. Toward this goal, we assemble biospecimen sample sets via rigorous SOP’s in cohorts designed to avoid bias. We provide these specimens and guidance regarding study design to Discovery Labs, industry and consortia. Team efforts between the DMCC, the Hopkins BRL, industry partners, UTHSC-SA and our CVC facilitated FDA approval of the Prostate Health Index (phi - with data from our CVC’s first cycle), and urinary PCA3 (with data from the current cycle). In two funding cycles, our CVC enrolled 4,821 subjects. We helped advance the TMPRSS2:Erg fusion (T2:Erg) discovery by the Chinnaiyan BDL toward actionable clinical use, completing 3 Aims with progress on the 4th: First, we combined urinary detection of T2:Erg with urinary PCA3 to improve specificity of detecting cancers with Gleason score > 7, validated this algorithm in a multi-center cohort, and showed the potential to reduce health care cost via this algorithm in men less than 65 years old. Second, we characterized community-based distribution of urinary T2:Erg, PCA3, and phi independent of PSA screening, and found racebased differences in these parameters, paving the way for a phase IV screening trial (separate proposal under review by DOD). Third, we compared prostatectomy tissue Erg expression to urinary T2:Erg, guiding the range of appropriate urinary T2:Erg cut-points to reflect tissue status. Fourth, we procured biopsies from two nationwide, retrospective watchful waiting cohorts (PHS and HPFS), enrolled subjects onto the PASS Trial, and assembled a biospecimen set suitable for evaluating multiplex RNA’s to discern aggressive from indolent disease. Recognizing limitations of T2:Erg as a classifier of cancer aggressiveness, we initiated clinical translation of a 24-gene, multiplex RNA panel for discerning aggressive from indolent prostate cancer; showed the feasibility of this assay in biopsy tissue and urine, and identified an industry partner to evaluate this signature on a clinical grade platform. We will expand our validation studies to include imaging to assess cancer severity based on FACBC, a PET radiotracer undergoing clinical development. We are expanding the breadth of our CVC from previously being limited to academic medical centers (AMC’s), to now including an urban indigent care hospital, a Veterans Administration Medical Center, and a suburban community hospital (in addition to our host AMC) so that we project enrolling 1050 African-American men, substantially diversifying the EDRN biospecimen resource. We now propose the following Aims: 1) To validate the combination of urine PCA3, T2:Erg and serum phi as predictive of aggressive prostate cancer de novo and for active surveillance; 2) To validate a multiplex RNA signature of aggressive prostate cancer in biopsy samples and post-DRE urine; 3) To validate FACBC as imaging to detect occult metastatic disease in high-risk, localized prostate cancer; 4) To collaborate with EDRN BDL’s, CVC’s and BRL’s to advance prostate cancer biomarker development.
H. Lee Moffitt Cancer Center and Research Institute Inc. Breast cancer (female), Lung

We propose to establish the Moffitt Imaging Biomarker Validation Center (MIBVAC) focused on imaging biomarker validations for early cancer detection a...

We propose to establish the Moffitt Imaging Biomarker Validation Center (MIBVAC) focused on imaging biomarker validations for early cancer detection and accurate risk assessments by leveraging our team of strong experts, resources, planned imaging biomarker validation studies, and analysis and network collaboration structures. In previous studies we have demonstrated that various measurements from breast images quantify breast cancer risk. The large cooperative National Lung Screening Trial (NLST) also showed a significant survival improvement for individuals screened by low dose CT compared to those screened with conventional radiography. Additionally, we have recently shown that CT image analysis (radiomics) can improve classification in this data set. However, due to difficulties in obtaining accurate and reproducible measurements and high false-positive rates of current imaging, cancer imaging biomarkers have not been routinely incorporated into clinical risk assessment. If these imaging biomarkers can be accurately tailored at the individual level, their impact will be significantly improved for early cancer detection and intervention. MIBVAC plans to achieve this challenging yet quite achievable goal by rigorously evaluating and validating these imaging biomarkers for rapid translation into clinical and practical applications. We have four specific aims: (Aim 1) Establish breast imaging resources for EDRN both with our existing and new case-control datasets of breast images and to evaluate and validate breast imaging biomarkers based on newly-established case-control dataset of digital breast tomosynthesis (TS) images, (Aim 2) Evaluate and validate lung imaging biomarkers for early detection of cancer first based on NLST low-dose CT (LDCT) cohorts and then expanding with a newly-established case-control cohort of higher resolution LDCT, (Aim 3) Conduct validation studies with imaging biomarkers for EDRN partners and others for other malignancies, and (Aim 4) Refine and validate imaging biomarkers analytically for early detection of breast, lung, and other cancers and to construct MIBVAC imaging data and specimen resources for EDRN collaborations and sharing.

Data Management and Coordinating Center

Site Investigator
Fred Hutchinson Cancer Research Center

The key for the Early Detection Research Network (EDRN)&#39;s success lies in good communication among scientists in multiple disciplines; efficient e...

The key for the Early Detection Research Network (EDRN)&#39;s success lies in good communication among scientists in multiple disciplines; efficient evaluation and prioritization of promising biomarkers; and rigorous validation studies to demonstrate their clinical utility. The overall aims of the proposed renewal of the Data Management and Coordinating Center (DMCC) are to (i) provide coordination of EDRN in order to enhance communication and collaboration among EDRN investigators and with general scientific communities; (ii) coordinate EDRN validation studies; (iii) disseminate cancer biomarker information to broader scientific communities and the public; and (iv) mange the EDRN Core funds. Under the direction of the EDRN Steering Committee, the DMCC will 1) perform network coordination and promote collaborations among scientific investigators by providing support for EDRN meetings and workshops, developing and maintaining EDRN secure websites and listservs, producing and maintaining all EDRN documents, and maintaining the online review system for applications submitted to the EDRN; 2) support EDRN validation studies by developing and maintaining validation study data management systems; working with EDRN investigator on study design, protocol development, data forms, and study manuals; coordinating and monitoring studies; tracking specimens; and performing QA/QC and study evaluation; 3) work with the NCI and JPL to provide informatics resources for the EDRN Secure Web site for data security, data warehousing, and data sharing, and a Public Web site for dissemination; and 4) work closely with the EDRN SC and the NCI Project Coordinator and FHCRC OSR to timely activate the core funds after the EDRN SC approval and ensure the compliance of all regulatory requirements for sub-award management.

Informatics Center

National Cancer Institute

Associate Members

This section lists associate EDRN members.

Associate Member A — EDRN Funded

Associate Member B

Site Investigator
AIBioTech
Baylor College of Medicine
Baylor College of Medicine
Beth Israel Deaconess Medical Center

Investigators at Dana Farber Cancer Institute in collaboration with Beth Israel- Deaconess Medical Center, Brigham and Women&#39;s Hospital, will stud...

Investigators at Dana Farber Cancer Institute in collaboration with Beth Israel- Deaconess Medical Center, Brigham and Women&#39;s Hospital, will study alpha-methylacyl-CoA racemase (AMACR) expression in cancerous tissues, and measure auto-antibody sera of patients that had cancers exhibiting aggressive pathological features and compare these among patients with more indolent prostate cancer. The primary hypothesis is that a humoral immune response to AMACR (as a prototype of various clinical measures related to prostate cancer-associated AMACR expression), or other candidate prostate antigens, is significantly associated with presence and severity of prostate cancer, and provides an opportunity for improvements in early detection of prostate cancer. This hypothesis will be addressed through evaluation of serum collected from three complementary clinical cohorts. Each of these cohorts provides complementary strengths and limitations in evaluating three aims that together address the study hypothesis as follows: <br><br>To compare specificity of anti-AMACR antibody to the specificity of PSA for detecting prostate cancer in a prospective case-control cohort of men undergoing prostate biopsy. 1800 biopsy cases will be enrolled for this Aim. <br><br><br>To validate the accuracy of humoral responses against tissue biomarkers, including AMACR, in detecting cancers and gauging cancer severity in the Physicians&#39; Health Study cohort, a community-based cohort of physicians with and without prostate cancer. This Aim involves the evaluation of 500 prostate cancer cases and 1500 controls.<br><br>To evaluate whether anti-AMACR auto-antibody or other humoral responses against prostatic tissue biomarkers can distinguish aggressive prostate cancers from early cancers at lower risk for extra-prostatic spread in a cohort of men treated for prostate cancer. This Aim will evaluate 1500 prostate cancer. <br>
Beth Israel Deaconess Medical Center
Biosite Incorporated
Biosystems International SAS
Brigham and Womens Hospital
Brigham and Womens Hospital
British Columbia Cancer Agency
British Columbia Cancer Research Centre/Cancer Genetics and Development Biology
Burlington Urology
CURC/Carolina Urologic Research Center
Cangen Biotechnologies Inc.
Case Western Reserve University
Cedars Sinai Medical Center
Center for Asbestos Related Diseases
Cleveland Clinic
Columbia University Medical Center
Cornell University
DKFZ-German Cancer Research Center
Dana Farber Cancer Institute-BWH
Eastern Virginia Medical School
Emory University School of Medicine
Exact Sciences
Fox Chase Cancer Center
Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Geisinger
Geisinger Health System
George Washington University
Georgetown University
Greenville Health System
H. Lee Moffitt Cancer Center and Research Institute, inc.
Harborview Medical Center
Henry Ford Health Systems
Hershey-Penn State Medical Center
Hologic Gen-Probe Incorporated
INOVA Diagnostics Inc.
Icahn School of Medicine at Mt. Sinai
Indiana University
Instituto Valenciano de Infertilidad
Johns Hopkins
Johns Hopkins Medical Institute
Johns Hopkins University
Johns Hopkins University
Johns Hopkins University
Johns Hopkins University
Johns Hopkins University Department of Urology

Despite major improvements in our ability to detect and stage prostate cancer, we continue to perform diagnostic biopsies unnecessarily on 75% of men ...

Despite major improvements in our ability to detect and stage prostate cancer, we continue to perform diagnostic biopsies unnecessarily on 75% of men with abnormal PSA levels, finding 1:4 with disease, we continue to understage nearly 30% of men with presumed localized disease, and we continue to lack additional clinically validated prostate cancer biomarkers. As the &quot;baby boomer&quot; men reach their 60&#39;s, it is anticipated that the number of men over age 50 will increase greatly, reaching 80 million by year 2015. There are nearly 20 million men in the U.S. who have had one negative prostate biopsy yet still are risk for prostate cancer and can no longer rely on PSA as their biomarker of choice. To address these problems, the Center will:<br><br>•<br>Continue discovery, characterization and validation of potential biomarkers for the early detection of prostate cancer; <br><br>Accrue patients, archive an impressive and clinically valuable biorepository of specimens, take part in collaborative research within the EDRN, industry and non-EDRN investigators, actively take part in the governance of the EDRN, and publish key biomarker findings; <br><br>•<br>Characterize novel tumor markers, conduct preliminary pilot studies of biomarkers, evaluate biomarker technologies, and develop multivariate tumor marker models for complex evaluation of multiple tumor markers.
Kaiser Permanente Los Angeles California
Kaiser Permanente Northern California
Kaiser Permanente Northern California
Kaiser Permanente San Francisco Medical Center
Kaiser Permanente Southern California
Kalloger Consulting
LURN-Daytona Beach
LURN-New Jersey
LURN-Orange City
Lab DKFZ-German Cancer Research Center
LabCorp Molecular Biology & Pathology
Massachusetts General Hospital
Mayo Clinic
Mayo Clinic
Mayo Clinic
Mayo Clinic Jacksonville
Mayo Clinic-Jacksonville
McGill University
Medical College of Georgia
Memorial Sloan Kettering Cancer Center
Memorial Sloan-Kettering
Memorial Sloan-Kettering Cancer Center
Miami Veterans Affairs Hospital
Moffitt Cancer Center
Montefiore Medical Center
Mount Sinai Hospital
Mount Sinai Medical Center
Mt. Sinai Medical Center
Mt. Sinai Medical Center
Multicare
National Cancer Institute
National Cancer Institute at Frederick
National Cancer Institute-PLCO
New York University School of Medicine
New York University School of Medicine

The NYU Lung Cancer Biomarker Center conducts lung cancer screening of Con Edison utility workers and others with 20 pack-years smoking ± asbestos exp...

The NYU Lung Cancer Biomarker Center conducts lung cancer screening of Con Edison utility workers and others with 20 pack-years smoking ± asbestos exposure, with spiral CT scans, induced sputum, respiratory questionnaires, pulmonary function tests, and blood collection. During the first five years of our EDRN funding over 1200 people have completed the survey. On CT scans, 50% had solid nodules, 10% ground-glass opacities, 5% pleural plaques, and 5% fibrosis. Eight lung cancers were diagnosed and an additional 69% had obstructive pulmonary function. The Center has enrolled 111 rule-out lung cancer patients and 60% were diagnosed with adenocarcinomas and identified a unique microarray pattern of lung preneoplasia (atypical adenomatous hyperplasia) with differential expression of Rab and Wnt pathways.
NorthShore University HealthSystem
Saint Louis University
San Diego Clinical Trials
San Diego State University
Source MDx
St Michael's Hospital
St. Joseph Mercy Health System
St. Michaels Hospital
St. Michaels Hospital
Stanford University
Stanford University
Stanford University
Stanford University Medical Center
Stanford University Medical Center
The Fe/Male Health Clinic
The Johns Hopkins University
The Male Health Centre
The Male/Female Health and Research Center
The Ohio State University
The Ohio State University Wexner Medical Center
The University of California San Francisco
The University of Texas MD Anderson Cancer Cente
The University of Texas MD Anderson Cancer Center
The Urology Group
Thomas Jefferson University
TwinStrand
UT Southwestern Medical Center
UT Southwestern Medical Center at Dallas
Univ of Michigan
University of Alabama at Birmingham
University of Alabama at Birmingham
University of British Columbia
University of Calgary Colon Cancer Screening Centre
University of California Irvine
University of California Los Angeles
University of California Los Angeles
University of California Los Angeles

The center has expertise and experience in microfludics-based proteomics technologies, micro-arrays, ELISA, tissue arrays, and other immunological bas...

The center has expertise and experience in microfludics-based proteomics technologies, micro-arrays, ELISA, tissue arrays, and other immunological based assays and methods. <br><br><br><br>The goals of the UCLA Biomarker Reference Laboratory (UCLA-BRL) are to: <br><br><br>• <br>Utilize our diverse infrastructure and highly skilled personnel to test, evaluate, quantify, and optimize detection of biomarkers useful early stage tumor marker. To this end, we have established Scientific Centers that can test for biomarkers in tissue (full tissue sections or &#39;intelligent&#39; high density tissue microarrays) and in fluids (by conventional ELISA and nanotech electrochemical chip). In addition, we have the resources to detect nucleic acids in body fluids as well as DNA modification and alterations in tissue, cells and/or fluids, <br><br><br>• <br>Develop new platforms and algorithms for biomarker detection and analysis. This includes the development and implementation, in conjunction with an industrial partner, of a high-throughput nano-detection chip for measuring biomarkers in fluids, and in-house pioneering research on mining biomarker profiles using tissue microarrays.<br><br><br>• <br>Continue a program at UCLA that is highly professional and focused, yet at the same time flexible and cost-effective in order to meet the challenges of an evolving EDRN program. <br>
University of California San Francisco
University of California San Francisco
University of Chicago
University of Chicago Urology Center
University of Florida
University of Illinois at Chicago
University of Kansas Medical Center
University of Miami

Changed from Allan Pollack to Sanoj Punnen in January, 2019...

Changed from Allan Pollack to Sanoj Punnen in January, 2019
University of Miami Miller School of Medicine
University of Miami Miller School of Medicine
University of Michigan

Category B Members contribute to the Network by sharing available technologies, contributing specimens, making available high-risk registries and coho...

Category B Members contribute to the Network by sharing available technologies, contributing specimens, making available high-risk registries and cohorts, and providing other resources complementary to the Network.
University of Michigan
University of Michigan
University of Michigan
University of Michigan
University of Michigan
University of Michigan
University of Michigan Pathology
University of Michigan Recruiting
University of Minnesota
University of Nebraska
University of Nebraska Medical Center
University of North Carolina
University of Pennsylvania
University of Pittsburgh
University of Puerto Rico Comprehensive Cancer Center
University of Rochester Medical Center
University of Southern California/Norris Cancer Center
University of Texas Health Science Center San Antonio
University of Toledo College of Medicine
University of Toronto
University of Washington
University of Washington
University of Washington
University of Western Australia
University of York

Lung Reference Set Applicant...

Lung Reference Set Applicant
Urotec
Utah CAncer Specialists - Murray Precision Genomics Cancer Research Clinic
VA Medical Center Seattle
Vanderbilt University
Vanderbilt University
Vejle Hospital
Wako Diagnostics
Washington University
Weill Cornell Medical College-Central Review
Weill Cornell Medicine-Urology
Wistar
Yale

Associate Member C

Site Investigator
20/20 GeneSystems Inc. Corp.
Abbott
Abbott Laboratories
Agilent, Inc.
AmberGen Inc.
Ambergen Inc.
Arizona Cancer Center
Arizona State University
Aspira Laboratory
AstraZeneca
Baylor

The long-term goal of my laboratory is to discover biomarkers for early detection, treatment monitoring, and outcome prediction of cancer patients. Pr...

The long-term goal of my laboratory is to discover biomarkers for early detection, treatment monitoring, and outcome prediction of cancer patients. Previousiy, i was a group leader in the piOteomics section of Genome Institute of Singapore where I took charge of setting up a clinical proteomics program. The mandate was to discover biomarkers from biofluids of liver and gastric cancer patients using advanced proteome profiling<br>technologies. I moved back to US in fall, 2006. My job was to set up a genomics and proteomics core<br>laboratory in Texas Children&#39;s Hospital. The purpose of the core laboratory is to provide advanced genomics and proteomcis technologies to researchers to discover biomarkers in pediatric cancers. The activity of the<br>laboratory is in seemless agreement with the objective of Early Detection Research Network (EDRN). I am applying for the Category C of Associate Membership. My contributions to the mission of EDRN through attending the meeting and workshops are as follows: 1) It will be very helpful for me to learn the current scientific practise from other principal investigators in the network. It stems from reproducibility, specificity, and sensitivity analyses in biomarker discovery phase, to validation, subsequently to phase II and III clinical<br>trials, and eventually to development of diagnostics. My future proposed study will be in line with the standards being established in EDRN. 2) I would like to establish a connection network with the principal<br>investigators in EDRN so that future collaborations will be nurtured. 3) I would like to contribute to the network in near future in terms of reagent, technologies, samples, or data sharing. My laboratory is<br>developing advanced genomics and proteomics technologies such as pulsed-field two-dimensional gel<br>electrophroesis and gel-based glycoproteome analysis for enhancing biomarker discovery in serum or plasma samples. I also have connections with physician scientists in China and Korea who are Willing to contribute reagents for clinical studies.,
Beckman Coulter
Beckman Coulter
Beckman Coulter
Beckman Research Institute at City of Hope Comprehensive Cancer Center
Beckman Research Institute of the City of Hope
Bio-Rad
Biochain Institute Inc.
Boston University

Four-dimensional light scattering fingerprinting (4D-ELF) can be used to analyze cellular architecture and to identify spectral makers that precede co...

Four-dimensional light scattering fingerprinting (4D-ELF) can be used to analyze cellular architecture and to identify spectral makers that precede conventional molecular markers of experimental colorectal cancer. These spectral markers will be validated using an endoscopically compatible 4D-ELF probe during colonoscopy.
Brigham and Womens Hospital

The Boston Clinical Epidemiology and Validation Center (CEVC) seeks continued participation in the EDRN now as the Partners-Southwestern Clinical Epid...

The Boston Clinical Epidemiology and Validation Center (CEVC) seeks continued participation in the EDRN now as the Partners-Southwestern Clinical Epidemiology and Validation Center. The mission of our joint center is to: <br><br><br>• <br>Conduct biomarker validation for ovarian (and other female) cancers by developing collaborative projects using our collective expertise in epidemiology, clinical oncology, biostatistics, and clinical biochemistry. <br><br><br>• <br>Develop and characterize auto-antibodies to cancer antigens whose development may offer a uniquely broad approach to disease control. Histologic subtypes of cancer may require multiple markers for detection; and a multiple marker panel would also increase the efficiency of screening for multiple cancers simultaneously. <br><br><br>• <br>Develop statistical techniques to combine information from multiple assays for efficient testing of multiple analytes.<br><br><br>• <br>Continue to refine and validate new assays for biomarkers in collaboration with EDRN investigators and industrial partners to create assays that meet clinical laboratory standards and are ready for further validation in the broader EDRN network. <br><br><br>• <br>Develop a &quot;standard ovarian cancer reference set&quot; composed of multiple identical sets of aliquots to facilitate preclinical and clinical validation of ovarian cancer biomarkers. These sets could fill a critical need for &quot;filtering&quot; the large number of biomarkers being proposed for detection of ovarian cancers in a manner that they all can be compared based on their performances. Promising biomarkers would be further evaluated using other cross-sectional and longitudinally collected specimens. <br>
Brigham and Womens Hospital
Brighton Consulting Group
CHRISTUS Santa Rosa Medical Center Hospital
CRUK Cambridge Research Institute
Centers for Disease Control

The Cervical Cancer Clinical Epidemiology and Validation Center (CC-CEVC) is seeking to define molecular signatures that are predictive for neoplastic...

The Cervical Cancer Clinical Epidemiology and Validation Center (CC-CEVC) is seeking to define molecular signatures that are predictive for neoplastic progression in cervical lesions and to serve as a resource center for collaborative efforts in the study of cervical cancer. Their focus is specifically on Human Papilloma Virus (HPV), a highly prevalent viral infection of the genital tract, which has been epidemiologically linked to cervical cancer. The major roles of the CC-CEVC are to: <br><br>•   expand the EDRN cervical cancer biorepository for phase 2 and early phase 3 biomarker validation by conducting a prospective study of women attending several colposcopy clinics. <br><br><br>•   provide technical expertise in validation study design to EDRN Biomarker Developmental Laboratories (BDLs) and other EDRN collaborators who are proposing candidate biomarkers to assure efficient and effective use of specimens in the biorepository, <br><br><br>•<br>assist in laboratory testing, as needed by EDRN collaborators, to facilitate rapid completion and evaluation of validation studies.
Commonwealth Scientific & Industrial Research Organisation
Creighton University

In three decades of study of hereditary cancer syndromes, Creighton University&#39;s Hereditary Cancer Institute has amassed a large resource of hered...

In three decades of study of hereditary cancer syndromes, Creighton University&#39;s Hereditary Cancer Institute has amassed a large resource of hereditary cancer families. We have the rapport with family members and the research experience to recruit members of these families for biomarker research. We have a large collection of biological specimens with extensive linked clinical and pedigree data. As a Clinical Epidemiology and Validation Center of the EDRN, We will use these resources in collaborative biomarker research. Our objectives are to: <br><br>•<br>Support EDRN collaborative studies by a. recruiting members of cancer-prone families for participation b. supplying specimens and associated data from our specimen repository. <br><br>•<br>Maintain and expand our registry of individuals at high risk of specific cancer types who are willing to participate in biomarker studies. We will enroll individuals who are carriers of hereditary cancer syndrome-associated germ-line mutations. <br><br><br>•<br>Develop a serum repository with annual samples recruited from high risk individuals. <br><br><br>•<br>Serve as a resource on hereditary cancer syndromes for other EDRN investigators.<br><br><br>•<br>Carry out the following research projects to study of the frequency of CDKN2A, MGMT, HLTF, APC, HIC1, p14 ARF, MINT31, MINT2, TIMP3, THBS1, and MLH1 methylation in Lynch syndrome colon adenomas and early colorectal cancers, and of the value of methylation assays of stool or serum DNA for detecting early methylation-positive colon neoplasms in Lynch syndrome patients.
Dana Farber Cancer Institute/Harvard Medical School
Drexel University College of Medicine

Individuals chronically infected with hepatitis B or C viruses are at high risk for the development of hepatocellular carcinoma (HCC). Given the limit...

Individuals chronically infected with hepatitis B or C viruses are at high risk for the development of hepatocellular carcinoma (HCC). Given the limitations of current clinical tools and the growing hepatitis population, advances in detection, diagnostic, and predictive models for HCC would have substantial health benefits.
Drexel University College of Medicine
Duke University
Duke University Medical Center
Emory University
Exploit Technologies PTE Ltd.
Fox Chase Cancer Center

Fox Chase will serve as a resource center for specimens for use in collaborative research and proposes to: <br><br>Assemble a multidisciplinary team o...

Fox Chase will serve as a resource center for specimens for use in collaborative research and proposes to: <br><br>Assemble a multidisciplinary team of investigators focused on early detection and risk assessment markers. <br><br><br>Develop meaningful collaborations with other EDRN centers and with regional institutions to foster early phase studies. <br><br><br>Establish procedures for study monitoring, managing protocols/projects as well as quality assurance and data sharing. <br><br><br>Conduct clinical biomarker validation studies for early detection of breast cancer utilizing proteomic techniques developed at Fox Chase Cancer Center and capability of detecting DNA hypermethylation in serum of patients at high risk for cancer. <br><br><br>FCCC will use its unique resources: 1) to assess the accuracy of biomarkers in predicting extent or severity of disease, 2) to evaluate gene environmental interactions, 3) and to understand risks and susceptibility in high risk cohorts. <br>
Fox Chase Cancer Center

This program is focusing on the development of markers for renal cancer primarily based on differential heypermethylation of cancer DNA sequences in r...

This program is focusing on the development of markers for renal cancer primarily based on differential heypermethylation of cancer DNA sequences in renal cancer and in urine of the same cancer patients as compared to healthy controls.
Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Genetica Inc.
Genteomics USA Inc.
Genteomics USA Inc.
GlaxoSmithKline
H. Lee Moffitt Cancer Center
H. Lee Moffitt Cancer Center
H. Lee Moffitt Cancer Center and Research Institute Inc.

We propose to establish the Moffitt Imaging Biomarker Validation Center (MIBVAC) focused on imaging biomarker validations for early cancer detection a...

We propose to establish the Moffitt Imaging Biomarker Validation Center (MIBVAC) focused on imaging biomarker validations for early cancer detection and accurate risk assessments by leveraging our team of strong experts, resources, planned imaging biomarker validation studies, and analysis and network collaboration structures. In previous studies we have demonstrated that various measurements from breast images quantify breast cancer risk. The large cooperative National Lung Screening Trial (NLST) also showed a significant survival improvement for individuals screened by low dose CT compared to those screened with conventional radiography. Additionally, we have recently shown that CT image analysis (radiomics) can improve classification in this data set. However, due to difficulties in obtaining accurate and reproducible measurements and high false-positive rates of current imaging, cancer imaging biomarkers have not been routinely incorporated into clinical risk assessment. If these imaging biomarkers can be accurately tailored at the individual level, their impact will be significantly improved for early cancer detection and intervention. MIBVAC plans to achieve this challenging yet quite achievable goal by rigorously evaluating and validating these imaging biomarkers for rapid translation into clinical and practical applications. We have four specific aims: (Aim 1) Establish breast imaging resources for EDRN both with our existing and new case-control datasets of breast images and to evaluate and validate breast imaging biomarkers based on newly-established case-control dataset of digital breast tomosynthesis (TS) images, (Aim 2) Evaluate and validate lung imaging biomarkers for early detection of cancer first based on NLST low-dose CT (LDCT) cohorts and then expanding with a newly-established case-control cohort of higher resolution LDCT, (Aim 3) Conduct validation studies with imaging biomarkers for EDRN partners and others for other malignancies, and (Aim 4) Refine and validate imaging biomarkers analytically for early detection of breast, lung, and other cancers and to construct MIBVAC imaging data and specimen resources for EDRN collaborations and sharing.
HonorHealth Research Institute
Houston Methodist Research Institute
Iceland Genomics Corporation
Indiana University
Insightful Inc.
Institute of Cancer Research
Instituto Nazionale Tumori Regina Elena
Johns Hopkins Medical Institutions
Johns Hopkins School of Medicine
Johns Hopkins University
Johns Hopkins University
Johns Hopkins University

Esophageal carcinoma is usually detected at an advanced stage, when available treatments are not very effective. Earlier detection of this cancer has ...

Esophageal carcinoma is usually detected at an advanced stage, when available treatments are not very effective. Earlier detection of this cancer has been shown to have a significant impact on patient outcome.
Johns Hopkins University
Johns Hopkins University School of Medicine
Johns Hopkins University School of Medicine

The Biomarkers Developmental Laboratory at the Johns Hopkins University has assembled a team of scientists to identify new biomarkers for non-small ce...

The Biomarkers Developmental Laboratory at the Johns Hopkins University has assembled a team of scientists to identify new biomarkers for non-small cell lung cancer (NSCLC).
Johns Hopkins University School of Medicine
Johns Hopkins University School of Medicine
Karmanos Cancer Institute
Lombardi Comprehensive Cancer Center
Lombardi Comprehensive Cancer Center
Lovelace Respiratory Research Institute
MD Anderson Cancer Center
MDxHealth Inc.
Mayo Clinic
Medical University of South Carolina
Medical University of South Carolina
Meharry Medical College School of Medicine
Meso Scale Diagnostics
Metabolon
Metabolon Inc.
Milagen Inc.
Mitchell Cancer Institute
Mitchell Cancer Institute
Mitchell Cancer Institute
Mount Sinai Hospital
Mount Sinai Medical Center
NOX Technologies
NanoInk Inc.
National Cancer Institute
National Cancer Institute Tumor Glycome Laboratory
National Institute of Standards and Technology

The Biomarkers Reference Laboratory at the National Institute of Standards and Technology (NIST) validates early cancer detection biomarker assays aut...

The Biomarkers Reference Laboratory at the National Institute of Standards and Technology (NIST) validates early cancer detection biomarker assays authorized by the NCI Program Staff and the EDRN Executive Committee. The NIST DNA Technologies Group is integrated into the EDRN network to provide: 1) technical support to reconfigure early detection cancer assays for high throughput and 2) analytical validation services for promising biomarkers and assay systems arising in Biomarker Developmental Laboratories of the EDRN.
National Institute of Standards and Technology
New York University School of Medicine
NextGen Sciences
Nidaan Inc.
North Dakota State University
NorthShore University HealthSystem
Northwestern University
Northwestern University Feinberg School of Medicine
Northwestern University Feinberg School of Medicine
Pacific Nanoscience Inc.
Pacific Northwest National Laboratory
Pacific Northwest National Laboratory
Perelman School of Medicine/University of Pennsylvania
Perelman School of Medicine/University of Pennsylvania
PrimeraDx
Private Consultant
Provista Diagnostics
Qorvo
Quanterix
Rheinische Friedrich-Wilhelms-Universitat
Roche Diagnostics
Samsung Medical Center
Sanford-Burnham Medical Research Institute
SomaLogic
Stanford University
Stanford University
The Ohio State University
The Ohio State University College of Pharmacy

Intraductal papillary mucinous neoplasms (IPMN) of the pancreas represent the only radiographically identifiable precursor lesion of pancreatic adenoc...

Intraductal papillary mucinous neoplasms (IPMN) of the pancreas represent the only radiographically identifiable precursor lesion of pancreatic adenocarcinoma. It is crucial to identify patients with IPMN prior to the development of invasive disease as the outcome following resection of invasive IPMN is similar to that of conventional adenocarcinoma. Biomarkers such as CEA have been previously investigated for their value in diagnosing patients with IPMN, however these single biomarkers have not been valuable in identifying either invasive or pre-invasive lesions. We propose here to study a novel class of biomarkers, microRNA, in the cystic fluid and cyst tissue of IPMN patients with low-risk (adenoma and borderline) and high-risk (carcinoma in situ). microRNAs are noncoding RNA and have been found to be differentially expressed in all cancers studied thus far including pancreatic cancer. We will extract RNA from the cystic fluid of the resected tissues in 50 patients with low- or high-risk IPMN. We will profile the expression of 446 microRNAs using sensitive real-time quantitative RT-PCR. Data will be plotted as a heatmap and hierarchical clustering will performed to classify low-risk from high-risk patients. In addition, PAM (predictive analysis of micro-array) algorithm will be used to select and rank order the top differentially expressed miRNAs in the cystic fluid of IPMN patients and to determine if the miRNA expression data could predict which class the samples fit (low risk or high risk). The miRNA expression in both the cyst tissue and cyst fluid from the low-risk and high-risk patients will be compared to the various demographic data that includes gender, age, preoperative radiographic characteristics and follow-up. We will also expression profile the miRNA in samples of cyst fluid collected by endoscopic ultrasound and these data will be directly compared to those data determined from the surgical specimens. The long term goal of this study is to identify a microRNA molecular signature in the cyst fluid obtained by endoscopic ultrasound to classify patients at risk for developing IPMN.<br><br>It is presently very difficult to predict if patients with cystic lesions of the pancreas are at risk to develop IPMN. This project will attempt to determine a microRNA molecular signature from cystic fluid and compare it to the signature in cystic tissue. If successful, this could produce a non invasive means to predict if a patient is at risk for developing IPMN.
The Ohio State University Medical Center
The University of Arizona
The University of Texas MD Anderson Cancer Center
The University of Texas MD Anderson Cancer Center

Focus on the development of biomarkers for the early detection of adenocarcinomas: lung, colon and pancreas....

Focus on the development of biomarkers for the early detection of adenocarcinomas: lung, colon and pancreas.
The University of Texas MD Anderson Cancer Center
The University of Texas MD Anderson Cancer Center

An integrated strategy will be followed to identify and characterize putative target loci on selected, specific chromosomes frequently implicated in p...

An integrated strategy will be followed to identify and characterize putative target loci on selected, specific chromosomes frequently implicated in pancreatic cancer, which harbor genes deleted (&quot;loss of function tumor suppressor genes&quot;) or overexpressed in pancreatic cancer (&quot;gain of function oncogenes&quot;). Target genes will be characterized using expression and methylation studies, microsatellite instability studies, and SNP analysis.
The University of Texas MD Anderson Cancer Center
The University of Texas MD Anderson Cancer Center

A multidisciplinary group focused on discovery and development of new markers for early detection of bladder cancer based on identification of molecul...

A multidisciplinary group focused on discovery and development of new markers for early detection of bladder cancer based on identification of molecular and epigenetic alterations in bladder cancer.
The University of Texas MD Anderson Cancer Center
Tongji Hospital/Tonji Medical College
Tongji Hospital/Tonji Medical College
Transgenomic Inc.
UT Health Science Center San Antonio
UT Southwestern Medical Center
UT Southwestern Medical Center
University of Alabama at Birmingham

The Biomarker Reference Laboratory (BRL) at the University of Alabama at Birmingham functions within the EDRN to develop, modify and trouble-shoot pot...

The Biomarker Reference Laboratory (BRL) at the University of Alabama at Birmingham functions within the EDRN to develop, modify and trouble-shoot potential methods of early detection prior to their entry into validation studies. Components of development will include conversion of methodologies to high-throughput methods, analysis of limitations, and development of standard-operating-procedures. The core group of investigators is drawn from the Program in Translational Research in Neoplasia in the Department of Pathology at UAB, and all of these investigators are committed to, and have expertise in, the analysis of biomarkers. The group includes pathologists and basic researchers with expertise in neoplastic processes of the skin, head and neck, lung, colorectum, pancreas, breast, ovary and cervix. <br><br><br><br>The laboratory will provide technical expertise in, and resources for, surface-enhanced laser desorption/ionization time-of-flight mass spectroscopy (SELDI-TOF-MS), multidimensional gel analysis, protein purification, high-throughput ELISA, multiplex immunoassays, construction of tissue matrix arrays (spotted and tissue cylinders), computerized cytomorphometric analysis, immunohistochemistry (bright field, fluorescent, confocal microscopy), in situ hybridization, single and multiplex real time quantitative PCR, other PCR techniques, immunomagnetic separations, tissue resources, and experimental design of validation studies.
University of California Davis
University of California Los Angeles
University of California Los Angeles
University of California San Diego
University of California San Francisco
University of California at Los Angeles
University of California at San Francisco

The Biomarkers Developmental Laboratory at the University of California at San Francisco has assembled a team of scientists to identify new biomarkers...

The Biomarkers Developmental Laboratory at the University of California at San Francisco has assembled a team of scientists to identify new biomarkers for breast cancer.
University of Copenhagen/Hvidovre Hospital
University of Georgia
University of Hawaii Cancer Center
University of Maryland
University of Maryland Baltimore
University of Massachusetts Boston
University of Michigan
University of Michigan
University of Michigan Medical Center
University of Michigan Medical School
University of Michigan Medical School
University of Michigan Medical School
University of Nebraska Medical Center

Develop early diagnostic tests for pancreatic cancer....

Develop early diagnostic tests for pancreatic cancer.
University of New Mexico
University of Pittsburgh Cancer Instititute
University of Pittsburgh Cancer Institute

An integrated multi-disciplinary approach will be used to identify biomarkers for colorectal cancer. The team includes basic cancer researchers and cl...

An integrated multi-disciplinary approach will be used to identify biomarkers for colorectal cancer. The team includes basic cancer researchers and clinicians supported by faculty with expertise in biostatistics/bioinformatics.
University of Texas at San Antonio
University of Toronto
University of Washington

This multidisciplinary group is applying a system biology approach, a discipline that is global, hypothesis- and discovery-driven, quantitative, integ...

This multidisciplinary group is applying a system biology approach, a discipline that is global, hypothesis- and discovery-driven, quantitative, integrative, and iterative. The proteomic approach is based on identification of differentially expressed secreted proteins between prostate or bladder cancers and the appropriate normal controls using the ICAT labeling and MS analysis as well as the analysis of glycosylated proteins.
University of Washington
Urological Sciences Research Foundation
VU Medical Center
Vanderbilt Medical Center
Vanderbilt Medical Center
Vanderbilt University Medical Center
Vanderbilt University Medical Center
Ventana
Ventana
Veridex LLC
Virginia Commonwealth University Massey Cancer Center
Weizmann Institute of Science
Xenomics
Yale University
Yale University School of Medicine
bioAffinity Technologies, Inc.
diaDexus

SPOREs

Non-EDRN Sites

This section lists non-EDRN sites.

Non-EDRN Site

Site Investigator
Abbott Diagnostics R&D
Atrium Medical Center
CanDiag Inc
Canary Foundation
Carle Cancer Center
Case Comprehensive Cancer Center/Case Western Reserve University
Cleveland Clinic
Clínica Las Condes/Universidad de Chile
Dana Farber Cancer Institute
Dana Farber Cancer Institute
Duke University
EIC Laboratories Inc.
Eppley Institute for Cancer Research/University of Nebraska Medical Center
Essentia Health Duluth CCOP
Exact Sciences
Food and Drug Administration
Food and Drug Administration
Forsyth Regional Cancer Center
Fred Hutchinson Cancer Research Center
Fujirebio Diagnostics Inc.
Genomic Health Inc.
Glycobond

Liver Reference Set Applicant...

Liver Reference Set Applicant
Grand Rapids Clinical Oncology Program
Gundersen Lutheran
Harvard Medical School
Henry Ford Hospital
Kumamoto University
Lab Corps
Lahey Hospital and Medical Center
Marshfield Clinic
Memorial Sloan Kettering Cancer Center
Mercy Physicians of Oklahoma
NASPCC/Mountain Foundation For Lung Cancer
Natalie Warren Bryant Cancer Center
National Cancer Center Research Institute
National Institute of Standards and Technology
North Eastern University
Northwestern University
Northwestern University Feinberg School of Medicine
Novartis
Novartis Institutes for BioMedical Research Inc.
Orange County Urological Associates
Pancreatic Cancer Action Network
Quest Diagnostics
Research Advocacy Network
Roswell Park Cancer Institute
SUNY Upstate Medical Hospital
Safety Mutual of the Chilean Chamber of Construction
Sanford Cancer Center Oncology Clinic

Preston Steen took over as PI for this site as of 08/01/2014...

Preston Steen took over as PI for this site as of 08/01/2014
Sanford Clinic North-Fargo
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins University
St. Vincent CCOP
Stanford University
Temple University
The Ohio State University Comprehensive Cancer Center
Tripler Army Medical Center
University of Arkansas Medical Sciences
University of Bari
University of Chicago
University of Chicago
University of Hawaii MBCCCOP
University of Kentucky

Lung Reference Set A applicant...

Lung Reference Set A applicant
University of Michigan
University of Washington
Upstate Carolina CCOP
Vanderbilt-Ingram Cancer Center
Wako Diagnostics
Weiss Memorial Hospital
Wichita CCOP
William Beaumont Hospital