Screening for Bladder Cancer
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Screening for Bladder Cancer|
- Since the marker tests will only be administered to individuals with a positive Hemastix test, these are eight possible outcomes (one case with all negative marker tests and seven cases with as least one positive marker tests). [ Time Frame: After last subject completes the study. ] [ Designated as safety issue: No ]
|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)|
60 years of age or older Smokers or history of smoking
Other: Specimen and questionnaires only
Specimen and questionnaires only
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848627
|Contact: Susan L. Kinsgton, LVN, CCRPfirstname.lastname@example.org|
|United States, New York|
|University of Rochester Medical Center||Recruiting|
|Rochester, New York, United States|
|Contact: EDWARD MESSING, MD 585-275-3345 email@example.com|
|United States, Texas|
|M.D. Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Colin Dinney, MD 713-792-3250 firstname.lastname@example.org|
|Principal Investigator: Colin Dinney, MD|
|Principal Investigator: H. Barton Grossman, MD|
|Quebec City, Quebec, Canada|
|Contact: YVES FRADET, MD 418-691-55 email@example.com|
|Principal Investigator:||Seth P. Lerner, MD||Baylor College of Medicine|