Microsatellite Analysis of Urinary Sediment in Detecting 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.

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