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.

Condition	Treatment or Intervention
Bladder Cancer stage 0 bladder cancer stage I bladder cancer transitional cell carcinoma of the bladder	Procedure: biological markers  Procedure: computed tomography  Procedure: cystoscopy  Procedure: cytologic sampling  Procedure: diagnostic test  Procedure: gene expression profiling  Procedure: loss of heterozygosity  Procedure: microsatellite instability

Further Study Details: 

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.

Ages Eligible for Study:  40 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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

Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States; Recruiting
California
      Stanford Cancer Center at Stanford University Medical Center, Stanford,  California,  94305-5826,  United States; Recruiting
Illinois
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States; Recruiting
Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21287,  United States; Recruiting
Michigan
      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0946,  United States; Recruiting
Missouri
      Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States; Recruiting
New York
      James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester,  New York,  14642,  United States; Recruiting
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
South Carolina
      Grand Strand Urology LLP, Myrtle Beach,  South Carolina,  29572,  United States; Recruiting
Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States; Recruiting
      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-4009,  United States; Recruiting
      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78229-3900,  United States; Recruiting
Canada, Ontario
      Toronto Sunnybrook Regional Cancer Centre, Toronto,  Ontario,  M4N 3M5,  Canada; Recruiting

Study chairs or principal investigators

Mark P. Schoenberg, MD,  Principal Investigator,  Sidney Kimmel Cancer Center   

Study ID Numbers:  CDR0000401496; JHOC-03123005; NCT00095589
Record last reviewed:  October 2004
Last Updated:  April 4, 2005
Record first received:  November 5, 2004
ClinicalTrials.gov Identifier:  NCT00095589
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08