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Sponsors and Collaborators: |
Baylor College of Medicine M.D. Anderson Cancer Center University of Rochester Laval University |
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Information provided by: | Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00848627 |
In the study proposed, up to 1,500 men age 60 and over with strong smoking histories will test their urine for the presence of blood daily for two 10-day testing periods with the Ames Hemastix. Individuals with even a solitary positive test will undergo a thorough urologic evaluation to determine the cause of hematuria and follow-up will continue for 2 years after completion of the study.
Condition | Intervention |
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Bladder Cancer |
Other: Specimen and questionnaires only |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Screening for Bladder Cancer |
Estimated Enrollment: | 1500 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | February 2015 |
Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Males
60 years of age or older Smokers or history of smoking
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Other: Specimen and questionnaires only
Specimen and questionnaires only
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Reduction of cancer mortality is a stated goal of the National Cancer Institute. Cancer of the bladder is the 4th most commonly diagnosed cancer and 7th leading cause of cancer death in the American men, and represents an important target for mortality-reducing efforts. Furthermore, these tumors, even in early (i.e. curable) stages, usually cause several easily detectable abnormalities, including hematuria, and the presence of abnormal tumor products that are shed into urine or lie within exfoliated malignant cells.
The overall goal of the proposed study is to gain information concerning the performance characteristics of three bladder cancer markers when combined with hematuria testing in detecting bladder cancer.
A mail back questionnaire, completed at the beginning of the study, will provide information about the participants and the results of testings will be reported after each testing period. Individuals with even a solitary positive test will undergo a thorough urologic evaluation to determine the cause of hematuria and follow-up will continue or 2 years after completion of the study. At the time of the evaluation, three bladder cancer marker tests, NMP22 Bladder Chek, ImmunoCyt and UroVysion FISH will be performed, but regardless of the results, a hematuria evaluation will be completed. Data will be updated continually.
The 10 day testing with Hemastix will be repeated 9 months after the first one is completed regardless of the outcome of the first testing.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
MD Anderson Cancer Center, Baylor College of Medicine, University of Rochester Medical Center and Laval University that contain within them county hospitals, Veterans Administrations Hospitals, fee-for-service clinics, and tertiary care facilities will enroll subjects. Each site will devise their own means of soliciting participants in the study.
Inclusion Criteria:
Exclusion Criteria:
Contact: Susan L. Kinsgton, LVN, CCRP | 713-798-8514 | slk@bcm.edu |
United States, New York | |
University of Rochester Medical Center | Recruiting |
Rochester, New York, United States | |
Contact: EDWARD MESSING, MD 585-275-3345 edward_messing@urmc.rochester.edu | |
United States, Texas | |
M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Colin Dinney, MD 713-792-3250 cdinney@mdanderson.org | |
Principal Investigator: Colin Dinney, MD | |
Principal Investigator: H. Barton Grossman, MD | |
Canada, Quebec | |
Laval University | Recruiting |
Quebec City, Quebec, Canada | |
Contact: YVES FRADET, MD 418-691-55 yves.fradet@crhdq.ulaval.ca |
Principal Investigator: | Seth P. Lerner, MD | Baylor College of Medicine |
Responsible Party: | Baylor College of Medicine ( Seth P. Lerner ) |
Study ID Numbers: | H-20395, 5 P50 CA091846 07 (PP-S2) |
Study First Received: | February 19, 2009 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00848627 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bladder cancer Smokers Hematuria |
Urinary Tract Neoplasm Cystocele Urologic Diseases Hematuria Urinary Bladder Diseases |
Urinary Bladder Neoplasms Urogenital Neoplasms Bladder Neoplasm Urologic Neoplasms |
Neoplasms Neoplasms by Site Urologic Diseases Urinary Bladder Diseases |
Urinary Bladder Neoplasms Urogenital Neoplasms Urologic Neoplasms |