Detection of Bladder Cancer by Microsatellite Analysis (MSA) of Urinary Sediment: Multi-Institutional Study
40 Years
N/A
Both
Bladder Cancer
Trial Information
Detection of Bladder Cancer by Microsatellite Analysis (MSA) of Urinary Sediment: Multi-Institutional Study
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Single Blind, Primary Purpose: Diagnostic
Principal Investigator
Mark P. Schoenberg, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000401496
NCT ID:
NCT00095589
Start Date:
August 2004
Completion Date:
Related Keywords:
- Bladder Cancer
- bladder cancer
- stage 0 bladder cancer
- stage I bladder cancer
- transitional cell carcinoma of the bladder
- Urinary Bladder Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
| M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
| Stanford Cancer Center | Stanford, California 94305-5824 |
| Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Birmingham, Alabama 35294 |
| Dan L. Duncan Cancer Center at Baylor College of Medicine | Houston, Texas 77030 |
| Grand Strand Urology, LLP | Myrtle Beach, South Carolina 29572 |
