Early Detection Research Network


Bladder cancer is the fourth most common malignancy of American men and the seventh most common malignancy of American women. Bladder cancer occurs in two clinically significant forms: (1) superficial (TNM: Ta, TIS, T1) and (2) invasive (TNM:>2). Seventy-five percent of individuals with bladder cancer have superficial disease, and only a minority (approximately 15%) are at risk for disease progression. Most individuals (approximately 70%) with superficial disease experience disease relapse over a 10-year period. The majority of recurrences occur within the first 2 years after the diagnosis. Therefore, these individuals require frequent surveillance for recurrence that includes cystoscopy and urine cytology every 3 months for 2 years and then anually, and radiographic evaluation of the upper urinary tract every year. the sensitivity and specificity of urinary cytology are 25-50% and 90-100%, respectively. The sensitivity and specificity of cystoscopy is 90-100% and 75%, respectively. Consequently, there is a need to improve the current practice of bladder cancer surveillance. Previous studies have shown the applicability of Microsatellite Analysis (MSA) to the diagnosis of bladder tumors. MSA can detect genetic changes indicative of carcinoma from urothelial cells obtained in voided urine specimens. The genetic profile of DNAA purified from urine is compared to that of DNA purified from peripheral lymphocytes that are considered "normal" for evidence of microsatellite instability (MSI) and loss of heterozygosity (LOH), which are genetic characteristics of epithelial tumors. MSA is considered positive if any of the 15 microsatellite markers included in a panel of 15 is positive.
Under Review
Detection of Bladder CA by Microsatellite Analysis (MSA)

Goal 1: To determine sensitivity and specificity of microsatellite analysis (MSA) of urine sediment, using a panel of 15 microsatellite markers, in detecting bladder cancer in participants requiring cystoscopy. This technique will be compared to the diagnostic standard of cystoscopy, as well as to urine cytology. Goal 2: To determine the temporal performance characteristics of microsatellite analysis of urine sediment. Goal 3: To determine which of the 15 individual markers or combination of markers that make up the MSA test are most predictive of the presence of bladder cancer.