Validation of a Urine-based Assay With Genomic Markers for Predicting Recurrence for Non-muscle Invasive Bladder Cancer
Completed
- Conditions
- Non-muscle Invasive Bladder Cancer
- Registration Number
- NCT02969109
- Lead Sponsor
- Genomic Health®, Inc.
- Brief Summary
A study to validate, in a prospective manner, the ability of the predefined Genomic Health bladder cancer assay to detect recurrence in patients undergoing surveillance for non-muscle invasive bladder cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 417
Inclusion Criteria
- Patients with a prior diagnosis of non-muscle invasive, ≤T1, urothelial cell carcinoma of the bladder scheduled to undergo surveillance cystoscopy.
Exclusion Criteria
- Patients younger than 18 years
- Patients with a diagnosis of small cell carcinoma, adenocarcinoma or squamous cell carcinoma of the bladder
- Patients who have had a cystectomy or prior diagnosis of muscle invasive disease (T2 or greater)
- Patients who are unable or unwilling to give informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The recurrence status based on the pathology results 1 year The Genomic Health bladder cancer assay results. 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institute for Prostate and Urologic Cancers - University of Minnesota
🇺🇸Minneapolis, Minnesota, United States