Detection of Bladder Cancer by Microsatellite Analysis (MSA) of Urinary Sediment: Multi-Institutional Study
- Compare the sensitivity and specificity of microsatellite analysis (MSA) of urine
sediment with cystoscopy and urine cytology for detecting bladder cancer in
participants undergoing cystoscopy.
- Determine the temporal performance characteristics of MSA in urine sediment from these
- 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 in these participants.
OUTLINE: This is a single-blind, multicenter, cohort study.
Urine and blood specimens are collected from all participants at baseline. Urine specimens
are examined using microsatellite analysis, urine cytology, and urinalysis. Patients in
groups 2 and 3 also undergo cystoscopy at baseline.
Patients in group 3 undergo cystoscopy, upper tract imaging (e.g., abdominal CT scan),
microsatellite analysis, urine cytology, and urinalysis every 3 months for 2 years in the
absence of progressive disease.
Microsatellite analysis, which identifies loss of heterozygosity using polymerase chain
reaction technique, is conducted for 15 markers: D4S243, D21S1245, FGA, D17S695, D16S476,
D9S171, IFN-A, D20S48, D13S802, D17S654, D16S310, THO1, D9S162, D9S747, and MBP.
PROJECTED ACCRUAL: A total of 500 participants (100 each for groups 1 and 2 and 300 for
group 3) will be accrued for this study.
Masking: Single Blind, Primary Purpose: Diagnostic
Mark P. Schoenberg, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Rochester, New York 14642|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||St. Louis, Missouri 63110|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|Stanford Cancer Center||Stanford, California 94305-5824|
|Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham||Birmingham, Alabama 35294|
|Dan L. Duncan Cancer Center at Baylor College of Medicine||Houston, Texas 77030|
|Grand Strand Urology, LLP||Myrtle Beach, South Carolina 29572|