Screening for Bladder Cancer
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.
Observational Model: Cohort, Time Perspective: Prospective
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).
After last subject completes the study.
Seth P. Lerner, MD
Baylor College of Medicine
United States: Institutional Review Board
|University of Rochester Medical Center||Rochester, New York 14642|
|M.D. Anderson Cancer Center||Houston, Texas 77030|