Ignite Creation Date:
2024-05-05 @ 9:13 PM
Last Modification Date:
2024-10-26 @ 10:01 AM
Study NCT ID:
NCT00848627
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2009-02-19
Brief Title:
Screening for Bladder Cancer
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Screening for Bladder Cancer
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In the study proposed up to 1500 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 ie 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5P50CA091846 | NIH | None | httpsreporternihgovquickSearch5P50CA091846 |