Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer (NCT00095589) | Clinical Trial Compass
CompletedNot Applicable
Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer
United States125 participantsStarted 2004-08
Plain-language 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 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.
Who can participate
Age range40 Years – 120 Years
SexALL
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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 carc…
Trial details
NCT IDNCT00095589
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins