Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT01284205
Eligibility Criteria:
Inclusion Criteria:
* histologically confirmed urothelial carcinoma of the bladder (high grade Ta or T1 papillary lesions, CIS)
* histologically confirmed diagnosis within 42 days of study treatment
* life expectancy of greater than 5 years
* ECOG performance status of 2 or less
* absence of urothelial carcinoma involving the upper urinary tract or prostatic urethra within 12 months from start of study treatment
Exclusion Criteria:
* current or previous history of muscle invasive bladder tumors (\>T2)
* current or previous history of lymph node and/or distant metastases from bladder cancer
* current evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the bladder
* current systemic cancer therapy
* previous immunotherapy for bladder cancer
* previous intravesical chemotherapy treatment
* contraindication to use BCG of known tolerance to BCG
* history of malignancy of any organ system within the past 5 years (with the exception of basal cell or squamous cell carcinoma, stage T1 prostate cancer, carcinoma in situ of the cervix, colon polyps)
* patients who cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy or biopsy)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01284205
Study Brief:
Protocol Section:
NCT01284205