Bladder Cancer Clinical Trial
Official title:
Evaluation of the Survivin Urine mRNA Assay to Estimate Risk of Bladder Cancer Found on Cystoscopy
Verified date | March 2008 |
Source | Fujirebio Diagnostics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
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.
Status | Completed |
Enrollment | 600 |
Est. completion date | November 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Fujirebio Diagnostics, Inc | Malvern | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Fujirebio Diagnostics, Inc. |
United States,
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