Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention |
|---|---|
|
Bladder Cancer |
Genetic: loss of heterozygosity analysis Genetic: microarray analysis Genetic: microsatellite instability analysis Other: cytology specimen collection procedure Other: laboratory biomarker analysis Procedure: computed tomography Procedure: cystoscopy |
| Study Type: | Interventional |
| Study Design: | Masking: Single Blind Primary Purpose: Diagnostic |
| Official Title: | Detection of Bladder Cancer by Microsatellite Analysis (MSA) of Urinary Sediment: Multi-Institutional Study |
| Estimated Enrollment: | 500 |
| Study Start Date: | August 2004 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Alabama | |
| Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Stanford Cancer Center | |
| Stanford, California, United States, 94305-5824 | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0942 | |
| United States, Missouri | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, South Carolina | |
| Grand Strand Urology, LLP | |
| Myrtle Beach, South Carolina, United States, 29572 | |
| United States, Texas | |
| Dan L. Duncan Cancer Center at Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78229-3900 | |
| Canada, Ontario | |
| Edmond Odette Cancer Centre at Sunnybrook | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Principal Investigator: | Mark P. Schoenberg, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00095589 History of Changes |
| Obsolete Identifiers: | NCT00185627 |
| Other Study ID Numbers: | CDR0000401496, JHOC-03123005, JHOC-J0382 |
| Study First Received: | November 5, 2004 |
| Last Updated: | February 26, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
bladder cancer stage 0 bladder cancer stage I bladder cancer transitional cell carcinoma of the bladder |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Urinary Bladder Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013