Trial Parameters
Brief 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 Criteria
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 90 days prior to scheduled BCG * Patients must have intermediate or high-grade bladder cancer as defined by 2004 WHO/ISUP classification * Patients must not have pure squamous cell carcinoma or adenocarcinoma. * Patients' disease must not have micropapillary components. * Patients must have no evidence of upper tract (renal pelvis or ureters) cancer confirmed by one of the following tests performe