Status:
COMPLETED
Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Bladder Cancer
Eligibility:
All Genders
40-120 years
Brief Summary
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 t...
Detailed Description
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 under...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00095589
Start Date
August 1 2004
End Date
June 1 2009
Last Update
February 8 2019
Active Locations (13)
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1
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
2
Stanford Cancer Center
Stanford, California, United States, 94305-5824
3
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
4
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410