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.
| Overal Status | Start Date | Phase | Study Type |
|---|---|---|---|
| Recruiting | Start Date: November 2015 | N/A | Observational |
Primary Outcome 1 - Measure: The recurrence status based on the pathology results
Primary Outcome 1 - Time Frame: 1 year
Primary Outcome 2 - Measure: The Genomic Health bladder cancer assay results.
Primary Outcome 2 - Time Frame: 1 year
Criteria:
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
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Keith Gran
Phone: 650-569-2042
Email: kgran@genomichealth.com
| Facility | Status | Contact |
|---|---|---|
| Institute for Prostate and Urologic Cancers - University of Minnesota Minneapolis, Minnesota 55455 United States |
Recruiting |
