NCT00903240CompletedNot Applicable
Phase 3 Study of Bladder Cancer Recurrence Surveillance
Predictive Biosciences20 sites in 1 country1,000 target enrollmentStarted: May 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,000
- Locations
- 20
Study Overview
Brief Summary
The purpose of this study is to detect recurrent bladder cancer using a combination of protein and DNA biomarkers in urine
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
Study Sites (20)
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