Survivin Urine mRNA Assay Risk of Bladder Cancer Study
Completed
Conditions studied: Bladder Cancer
In brief
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 bladder cancer presenting with microscopic or macroscopic hematuria.
Key facts
- Study ID
- NCT00315653
- Run by
- Fujirebio Diagnostics, Inc.
- People needed
- 600
- Starts
- 2005-09-01
- Expected to finish
- 2007-11-01
- Last updated by the study team
- 2008-03-14
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Fujirebio Diagnostics, Inc — Malvern, Pennsylvania, United States
Full record on ClinicalTrials.gov
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