Observational Study of Subjects Having Routine Recurrence Screening for Bladder Cancer
Phase 3 Study of Bladder Cancer Recurrence Surveillance
1 other identifier
observational
1,000
1 country
20
Brief Summary
The purpose of this study is to detect recurrent bladder cancer using a combination of protein and DNA biomarkers in urine
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2009
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 14, 2009
CompletedFirst Posted
Study publicly available on registry
May 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedJune 8, 2011
November 1, 2009
11 months
May 14, 2009
June 7, 2011
Conditions
Eligibility Criteria
The study population will be from urology and oncology practices
You may qualify if:
- Intact bladder
- Scheduled for cystoscopy for transitional cell bladder cancer recurrence screening
- Urine donated prior to cystoscopy, Bladder biopsy, chemotherapy, intravesical therapy, radiation or TUR
- Must be willing to sign IRB approved informed consent
You may not qualify if:
- History or current diagnosis of any cancer except transitional cell bladder cancer or basal cell cancer
- Known diagnosis of any autoimmune disease or HIV, HCV or HBV
- History or current TB or any other active infection
- Subject has gross hematuria
- Receiving chemotherapy, intravesical therapy or radiation within 30 days of enrollment
- Any surgery except urologic within past 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
BCG Oncology
Phoenix, Arizona, 85032, United States
Urology Associates
Engelwood, Colorado, 80113, United States
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, 55901, United States
Metro Urology
Woodbury, Minnesota, 55125, United States
Associates in Urology/Urology Group of NJ
741 Northfield Avenue, New Jersey, 07052, United States
Coastal Urology Associates
Brick, New Jersey, 08723, United States
Capital Regional Urological Surgeons
Albany, New York, 12208, United States
Community Care Physicians
Albany, New York, 12208, United States
University Urology Associates
New York, New York, 10016, United States
Hudson Valley Urology
Poughkeepsie, New York, 12601, United States
Associated Medical Professionals
Syracuse, New York, 13210, United States
The Urology Group
Cincinnati, Ohio, 45212, United States
Urological Associates of Lancaster
Lancaster, Pennsylvania, 17601, United States
Triangle Urologic Group
Pittsburgh, Pennsylvania, 15212, 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
The specimens to be retained are urine only
Study Officials
- STUDY DIRECTOR
Ellen Sheets, MD
Predictive Biosciences
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 14, 2009
First Posted
May 18, 2009
Study Start
May 1, 2009
Primary Completion
April 1, 2010
Study Completion
October 1, 2010
Last Updated
June 8, 2011
Record last verified: 2009-11