Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Detection of Bladder Cancer by Microsatellite Analysis (MSA) of Urinary Sediment: Multi-Institutional Study

Conditions
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Bladder Cancer

Intervention / Treatment
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* Genetic: loss of heterozygosity analysis
* Genetic: microarray analysis
* Genetic: microsatellite instability analysis
* Other: cytology specimen collection procedure
* Other: laboratory biomarker analysis
* Procedure: computed tomography
* Procedure: cystoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: loss of heterozygosity analysis|nan|
|Genetic: microarray analysis|nan|
|Genetic: microsatellite instability analysis|nan|
|Other: cytology specimen collection procedure|nan|
|Other: laboratory biomarker analysis|nan|
|Procedure: computed tomography|nan|
|Procedure: cystoscopy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bladder cancer, stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder