Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-25 @ 5:07 AM
NCT ID:
NCT00848627
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT00848627
Study Brief:
Protocol Section:
NCT00848627