Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer
RATIONALE: New diagnostic procedures such as microsatellite analysis of sediment in the urine may improve the ability to detect bladder cancer without invasive procedures.
PURPOSE: Diagnostic trial to study the effectiveness of microsatellite analysis of sediment in the urine in detecting bladder cancer in healthy participants, participants who have genitourinary conditions requiring cystoscopy, and patients who have bladder cancer.
Genetic: loss of heterozygosity analysis
Genetic: microarray analysis
Genetic: microsatellite instability analysis
Other: cytology specimen collection procedure
Other: laboratory biomarker analysis
Procedure: computed tomography
|Study Design:||Masking: Single Blind
Primary Purpose: Diagnostic
|Official Title:||Detection of Bladder Cancer by Microsatellite Analysis (MSA) of Urinary Sediment: Multi-Institutional Study|
|Study Start Date:||August 2004|
|Estimated Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
- 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 participants.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00095589
|United States, Alabama|
|Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|Stanford Cancer Center|
|Stanford, California, United States, 94305-5824|
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0942|
|United States, Missouri|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|James P. Wilmot Cancer Center at University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|United States, South Carolina|
|Grand Strand Urology, LLP|
|Myrtle Beach, South Carolina, United States, 29572|
|United States, Texas|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Dan L. Duncan Cancer Center at Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78229-3900|
|Edmond Odette Cancer Centre at Sunnybrook|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||Mark P. Schoenberg, MD||Sidney Kimmel Comprehensive Cancer Center|