Hematuria Evaluation Trial for Subjects With Microscopic or Gross Hematuria to Determine the Absence or Presence of Bladder Cancer
Phase 3 Study of Hematuria Evaluation
1 other identifier
observational
1,400
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2009
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 10, 2009
CompletedFirst Posted
Study publicly available on registry
September 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedJune 8, 2011
November 1, 2009
1.3 years
September 10, 2009
June 7, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
To establish the performance characteristics of the Predictive Biosciences Assay relative to the cystoscopy results for subjects undergoing evaluation for the referral diagnosis of gross or microscopic hematuria
Initial Visit only
Secondary Outcomes (1)
To establish the performance characteristics of the PB assay relative to urine cytology results for subjects undergoing evaluation for the referral diagnosis of gross or microscopic hematuria.
Initial Visit
Study Arms (1)
Subjects with hematuria
Eligibility Criteria
Subjects will be selected from Urology and Oncology practices.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Atlantic Urological Associates
Daytona Beach, Florida, 32114, United States
Winter Park Urology
Orlando, Florida, 32803, United States
Metropolitan Urology
Jeffersonville, Indiana, 47130, United States
Mayo Validation Support Services
Rochester, Minnesota, 55905, United States
Coastal Urology Associates
Brick, New Jersey, 08723, United States
Associates in Urology
Orange, New Jersey, 07052, United States
Community Care Physicians
Albany, New York, 12208, United States
Hudson Valley Urology
Poughkeepsie, New York, 12601, United States
Eastern Urological Associates
Greenville, North Carolina, 27834, United States
The Urology Group
Cincinnati, Ohio, 45212, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Urology Clinics of North Texas
Dallas, Texas, 75231, United States
Urology San Antonio Research
San Antonio, Texas, 78229, United States
Biospecimen
urine sample
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 10, 2009
First Posted
September 11, 2009
Study Start
July 1, 2009
Primary Completion
November 1, 2010
Study Completion
January 1, 2011
Last Updated
June 8, 2011
Record last verified: 2009-11