Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins125 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

125

Conditions

Bladder Cancer

Interventions

loss of heterozygosity analysisGENETIC

microarray analysisGENETIC

microsatellite instability analysisGENETIC

cytology specimen collection procedure

Eligibility

Sex: ALLMin age: 40 YearsMax age: 120 YearsHealthy volunteers:

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Group 1 (healthy volunteers): * No prior or concurrent urologic disease or devices * No genitourinary (GU) complaints, including urgency or frequency of urination * Normal urinalysis and urine cytology * Never smoked cigarettes regularly (i.e., ≥ 1 cigarette/day for ≥ 1 year) * No suspected exposure to environmental bladder carcinogens for \> 1 year, including, but not limited to, the following occupations or exposures: * Aluminum industry * Aromatic amines * Coal gasification * Coal tars and pitches * Coke plant * Dye industry * Leather industry * Machinist * Painter * Rubber industry * Truck, bus, or taxi drivers * Group 2 (participants with condition(s) that lead to false-positive urinary bladder cancer screening studies): * GU complaints requiring cystoscopy * No current GU malignancy * At least 1 of the following conditions: * Benign prostatic hypertrophy (International Prostate Symptom Score \> 12) * Foreign bodies (stones, stents, or catheters) * Hematuria (gross or microscopic) * GU infection (e.g., prostatitis, urinary tract infection, pyelonephritis, urethritis) within the past 3 months and completed treatment * No sign of infection at the time of study participation * Group 3 (superficial bladder cancer patients): * Histologically confirmed superficial bladder urothelial malignancy * Primary or recurrent disease * No nontransitional cell carcinoma of the bladder, upper tract tumors, muscle-invasive tumors, or superficial disease for which local therapy is not appropriate PATIENT CHARACTERISTICS: Age * Over 40 Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * See Disease Characteristics Other * No prior cancer except nonmelanoma dermatologic malignancy * Prior bladder cancer allowed for group 3 patients PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy * Prior intravesical therapy for bladder cancer allowed for group 3 patients Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy Surgery * Not specified

Locations (13)

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

Birmingham, Alabama, United States

Stanford Cancer Center

Stanford, California, United States

Data from ClinicalTrials.gov

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