Status:
COMPLETED
Screening for Bladder Cancer
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
M.D. Anderson Cancer Center
University of Rochester
Conditions:
Bladder Cancer
Eligibility:
MALE
60+ years
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. Indivi...
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 m...
Eligibility Criteria
Inclusion
- Men age 60 and over, - who are current cigarette smokers OR - who have a history of at least 20 pack years smoking OR - who have over a 30 pack/year history who have stopped smoking within 10 years of the registration date OR - who have a 40 pack year history of smoking regardless of the quit date, will be eligible for participation.
- Patients with prostate or renal cancer must have been treated more than 5 years previously and be considered disease-free at the time of entry. In the case of prostate cancer, patients may have only received prostatectomy as their treatment and must have undetectable PSA's at study entry.
- In the case of calculus disease, patients must be believed to be stone free at time of study entry and could not have had a stone attack within the previous 2 years.
- Patients receiving anticoagulation therapy, such as Warfarin, Plavix, Lovenox, aspirin, etc. will be able to take part in the study and, will be thoroughly worked-up if the only explainable cause of hematuria is receiving anticoagulation medication.
Exclusion
- history of urothelial cancer
- any malignancy other than non-melanoma skin cancers treated within the past 5 years
- benign tumors of the urinary tract that are still existent
- known urinary calculi
- medical or oncological conditions known to produce hematuria (e.g. glomerulonephritis, treatments with cyclophosphamide, methotrexate and pelvic radiation therapy)
- visual, psychological, neurological, musculoskeletal, etc. impairments that would make home testing impractical
Key Trial Info
Start Date :
March 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT00848627
Start Date
March 1 2007
End Date
February 1 2012
Last Update
February 25 2020
Active Locations (3)
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1
University of Rochester Medical Center
Rochester, New York, United States
2
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
3
Laval University
Québec, Quebec, Canada