Early Detection Research Network

Liver

Since 90% of patients with hepatocellular carcinoma (HCC) have underlying cirrhosis, patients with cirrhosis are candidates for HCC surveillance. Despite advances in medical technology, the 5-year survival of patients with HCC has improved minimally from 2% to 5% from 1981 to 1998. This may be largely due to diagnosis at late stage disease. These studies aim to compare the performance characteristics of the biomarkers AFP, DCP (des-gamma carboxyprothrombin) and AFP-L3 (lectin-bound AFP) in the early diagnosis of HCC.
http://edrn.jpl.nasa.gov/bmdb/biomarkers/organs/37/57
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AFP-L3 has been approved by the FDA as a component of lab test to diagnose the risk of developing liver cancer in patients with chronic liver disease (CLD). The test measures levels of both AFP-L3 and AFP in the blood, and calculates AFP-L3 levels as a percentage of total AFP. Higher levels of AFP-L3 are associated with higher risk of developing liver cancer. According to the FDA, if the percentage of AFP-L3 is greater or equal to 10%, the risk is seven-fold that the patient will develop liver cancer in the next 21 months.
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Contents
Validation of Serum Markers for the Early Detection of Hepatocellular Carcinoma

Using the guidelines for cancer biomarker validation suggested by Pepe et al. (23), we propose to perform a Phase 2 study of DCP for the detection of early stage HCC. In this proposal, we plan to perform a larger case-control study to compare the sensitivity and specificity of DCP and AFP alone and in combination in differentiating patients with all stages of HCC and more importantly those with early HCC from patients with cirrhosis. We plan to enroll consecutive patients with HCC seen at 7 centers in the United States. Controls are frequency matched to cases (all center combined) using the following criteria: age (±10 years), gender (+10%) and etiology of liver disease (viral vs non-viral (+5%). Within each participating institution, there will be an equal number (+20%) of cases and controls.

Liver Rapid Reference Set Application: Timothy Block - Drexel Univ (2008)

The goal of this application is to determine if the levels of serum GP73 and fucosylated kininogen/acute phase proteins can be used to detect hepatocellular carcinoma (HCC) in the background of liver cirrhosis. The use of the validation set would allow us to directly compare GP73 and fucosylated markers against AFP, AFP-L3 and DCP as well as test them in combination with these markers

Liver Full Reference Set Application :Timothy Block - Drexel Univ (2010)

The goal of this application is to determine if the levels of serum GP73 and fucosylated kininogen/acute phase proteins can be used to detect hepatocellular carcinoma (HCC) in the background of liver cirrhosis. The use of the validation set would allow us to directly compare GP73 and fucosylated markers against AFP, AFP-L3 and DCP as well as test them in combination with these markers

Liver Rapid Reference Set Application: Kevin Qu-Quest (2011)

We propose to evaluate the performance of a novel serum biomarker panel for early detection of hepatocellular carcinoma (HCC). This panel is based on markers from the ubiquitin-proteasome system (UPS) in combination with the existing known HCC biomarkers, namely, alpha-fetoprotein (AFP), AFP-L3%, and des-y-carboxy prothrombin (DCP). To this end, we applied multivariate logistic regression analysis to optimize this biomarker algorithm tool.

Liver Rapid Reference Set Application: Hiro Yamada - Wako (2011)

Measure clinical effectiveness of AFP-L3 and DCP for early detection of HCC in patient samples collected prospectively during surveillance. However since such samples are not readily available in the USA the reference set samples are well characterized and studied, gaining access to these samples will allow Wako to quickly measure clinical effectiveness of AFP-L3 and DCP in detecting early HCC.

Liver Full Reference Set Application: Hiro Yamada - Wako (2011)

Wako has received new 510(k) clearance for Lens culinaris agglutinin-reactive fraction of alpha-fetoprotein (AFP-L3) and Des-gamma-carboxy prothrombin (DCP) tests on an innovative μTASWako i30 analyzer from FDA. The AFP-L3 and DCP assayed on an older platform LiBASys have been cleared with indication of use for risk assessment of hepatocellular carcinoma (HCC) in patient at risk for the liver malignancy. Wako believes that early detection of HCC is critical for improving HCC patient outcome. Therefore, Wako is currently seeking collaborative opportunities to retrospectively measure clinical samples using the AFP-L3 and DCP for further determining of effectiveness of the HCC biomarkers in early detection which are collected prospectively during HCC surveillance. The Reference Sample Set in the EDRN biorepository are well characterized and studied. Access to these samples would allow Wako to quickly determine the clinical effectiveness of AFP-L3 and DCP in detecting early HCC