Bladder Cancer Clinical Trial
Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer
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.
Full 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 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.
Eligibility 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
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There are 12 Locations for this study
Birmingham Alabama, 35294, United States
Stanford California, 94305, United States
Chicago Illinois, 60637, United States
Baltimore Maryland, 21231, United States
Ann Arbor Michigan, 48109, United States
Saint Louis Missouri, 63110, United States
New York New York, 10021, United States
Rochester New York, 14642, United States
Myrtle Beach South Carolina, 29572, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Toronto Ontario, M4N 3, Canada
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