|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00095589 |
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 |
Procedure: computed tomography Procedure: cystoscopy Procedure: cytology specimen collection procedure Procedure: gene expression profiling Procedure: laboratory biomarker analysis Procedure: loss of heterozygosity analysis Procedure: microsatellite instability analysis |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Single Blind |
| 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
Secondary
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 suspected exposure to environmental bladder carcinogens for > 1 year, including, but not limited to, the following occupations or exposures:
Group 2 (participants with condition(s) that lead to false-positive urinary bladder cancer screening studies):
At least 1 of the following conditions:
GU infection (e.g., prostatitis, urinary tract infection, pyelonephritis, urethritis) within the past 3 months and completed treatment
Group 3 (superficial bladder cancer patients):
Histologically confirmed superficial bladder urothelial malignancy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
No prior cancer except nonmelanoma dermatologic malignancy
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No prior chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| United States, Alabama | |
| Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Clinical Trials Office - Lurleen Wallace Comprehensive Cancer 205-934-0309 | |
| United States, California | |
| Stanford Cancer Center | Recruiting |
| Stanford, California, United States, 94305-5824 | |
| Contact: Clinical Trials Office - Stanford Cancer Center 650-498-7061 cctoffice@stanford.edu | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | Recruiting |
| Chicago, Illinois, United States, 60637-1470 | |
| Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
| Baltimore, Maryland, United States, 21231-2410 | |
| Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | Recruiting |
| Ann Arbor, Michigan, United States, 48109-0942 | |
| Contact: Clinical Trials Office - University of Michigan Comprehensive 800-865-1125 | |
| United States, Missouri | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Adam S. Kibel, MD 314-362-8295 kibela@wustl.edu | |
| United States, New York | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Edward M. Messing, MD, FACS 585-275-3345 edward_messing@urmc.rochester.edu | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Guido Dalbagni, MD 646-422-4394 dalbagng@mskcc.org | |
| United States, South Carolina | |
| Grand Strand Urology, LLP | Recruiting |
| Myrtle Beach, South Carolina, United States, 29572 | |
| Contact: Clinical Trials Office - Grand Strand Urology, LLP 843-839-1679 | |
| United States, Texas | |
| Dan L. Duncan Cancer Center at Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor 713-798-1297 | |
| M. D. Anderson Cancer Center at University of Texas | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |
| University of Texas Health Science Center at San Antonio | Recruiting |
| San Antonio, Texas, United States, 78229-3900 | |
| Contact: Joseph W. Basler, MD, PhD 210-567-5643 basler@uthscsa.edu | |
| Canada, Ontario | |
| Edmond Odette Cancer Centre at Sunnybrook | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact: Laurence H. Klotz, MD 416-480-5000 | |
| Principal Investigator: | Mark P. Schoenberg, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000401496, JHOC-03123005, JHOC-J0382 |
| Study First Received: | November 5, 2004 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00095589 |
| Health Authority: | Unspecified |
|
bladder cancer stage 0 bladder cancer stage I bladder cancer transitional cell carcinoma of the bladder |
|
Cystocele Urologic Diseases Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms Urologic Neoplasms |
Carcinoma, Transitional Cell Transitional cell carcinoma Urinary tract neoplasm Bladder neoplasm Carcinoma |
|
Neoplasms Neoplasms by Site |
