Bladder Cancer Clinical Trial
Official title:
Detection of Bladder Cancer by Microsatellite Analysis (MSA) of Urinary Sediment: Multi-Institutional Study
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.
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
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