Status:
COMPLETED
Survivin Urine mRNA Assay Risk of Bladder Cancer Study
Lead Sponsor:
Fujirebio Diagnostics, Inc.
Conditions:
Bladder Cancer
Eligibility:
All Genders
50+ years
Brief Summary
The purpose of this clinical trial is to evaluate the ability of urinary Survivin mRNA measurement to estimate the risk of bladder cancer at the time of cystoscopy in subjects with no prior history of...
Detailed Description
Bladder cancer is the fourth most common cancer in men and ninth most common cancer in women, accounting for more than 60,000 new cases and \~12,000 deaths in North America in 2004. Cystoscopy and uri...
Eligibility Criteria
Inclusion
- Able to understand and sign Informed Consent;
- Age \>50 years old;
- Males or females;
- Subjects must have confirmed micro-hematuria, defined as any positive urine reagent strip test for blood (i.e. finding of "Trace" or higher amounts of blood) and/or \>3 RBC per high power field on microscopic examination, or macro-hematuria, defined as visible blood in the urine sample;
- All subjects must be scheduled to undergo a cystoscopy evaluation;
- All subjects must have upper tract imaging performed within +/- 4 weeks of the cystoscopic evaluation.
Exclusion
- Previous history of bladder cancer;
- Previous history of other cancers except for non-melanoma skin cancer;
- Prior pelvic radiation;
- Active urinary or vaginal infection;
- Any evidence of vaginal or rectal bleeding;
- Currently receiving chemotherapies such as cyclophosphamide or methotrexate;
- Unable to provide informed consent or a high risk that the subject may not comply with the protocol requirements.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
OBSERVATIONAL
End Date :
November 1 2007
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00315653
Start Date
September 1 2005
End Date
November 1 2007
Last Update
March 14 2008
Active Locations (1)
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1
Fujirebio Diagnostics, Inc
Malvern, Pennsylvania, United States, 19355