Status:
COMPLETED
Hematuria Evaluation Trial for Subjects With Microscopic or Gross Hematuria to Determine the Absence or Presence of Bladder Cancer
Lead Sponsor:
Predictive Biosciences
Conditions:
Microscopic or Gross Hematuria
Eligibility:
All Genders
45+ years
Brief Summary
The purpose of the study is to evaluate subjects with gross or microscopic hematuria undergoing scheduled cystoscopy to determine the absence or presence of bladder cancer.
Eligibility Criteria
Inclusion
- For those subjects for whom there is no family history of bladder cancer or less than a 20 pack year history of cigarette smoking, subject must be 50 or older.
- Subject's age can be lowered to 45 or older if there is a family history of bladder cancer and/or a 20 or greater pack history of cigarette smoking.
- Subject must have an intact bladder
- Subject must be scheduled to have a cystoscopy to screen for transitional call bladder cancer due to the finding of hematuria.
- Subject must be able to provide a minimum of 25 mL of urine for study purposes.
- Urine samples must be available prior to cystoscopy, bladder biopsy, and TUR.
- Subjects must be willing to sign an Institutional Review Board approved written informed consent prior to any study related procedures being performed.
Exclusion
- Subject had a history or current diagnosis of any basal or squamous cell cancer.
- Subject had a known diagnosis of any autoimmune disease.
- Subject had known diagnosis of HIV, HCV or HBV
- Subject had disclosed voluntarily history of or current infection with TB or other systemic disease.
- Subject is currently pregnant or lactating.
- Subject had surgery within 30 days prior to enrollment
- Subject has known allergy to benzalkonium chloride.
- Subject participated in an investigational drug or device trial within 30 days prior to enrollment.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT00975455
Start Date
July 1 2009
End Date
January 1 2011
Last Update
June 8 2011
Active Locations (13)
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1
Atlantic Urological Associates
Daytona Beach, Florida, United States, 32114
2
Winter Park Urology
Orlando, Florida, United States, 32803
3
Metropolitan Urology
Jeffersonville, Indiana, United States, 47130
4
Mayo Validation Support Services
Rochester, Minnesota, United States, 55905