A Novel Multiplex Immunoassay for Predicting Intravesical BCG Response in Patients With Intermediate or High-risk Non-muscle Invasive Bladder Cancer
Cedars-Sinai Medical Center
Summary
To date, there are no diagnostics capable of predicting treatment response to intravesical BCG. Because of this severe limitation, nearly 50% of patients treated with BCG fail therapy and will a) require additional intravesical therapy or b) require cystectomy. A urine-based diagnostic that possesses the potential to accurately identify patients who will respond favorably to intravesical BCG is desperately needed.
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 18 years or older * Patients must have histologically proven Ta, carcinoma in situ (CIS) or T1 stage urothelial cell carcinoma of the bladder diagnosed within 90 days prior to scheduled BCG * Patients must have had all grossly visible papillary tumors removed within 30 days prior to scheduled BCG or cystoscopy confirming no grossly visible papillary tumors within 30 days prior to scheduled BCG * Patients with T1 disease must have cross-sectional imaging of abdomen/pelvis demonstrating no evidence of nodal involvement or metastatic disease (CT scan or MRI scan) within…
Locations (5)
- Cedars-Sinai Medical CenterLos Angeles, California
- UCLALos Angeles, California
- UCSFSan Francisco, California
- University of Texas SouthwesternDallas, Texas
- Kyoto UniversityKyoto, Kyoto