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:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT02326168
Eligibility Criteria:
Inclusion Criteria:
The patient must:
* Be 18 years of age or older
* Be able to give informed consent
* Have newly diagnosed or recurrent multi-focal Ta, Large Ta, High Grade Ta, CIS or T1 Bladder Cancer
* Determined by treating urologist to be a good candidate for BCG Induction Therapy
* Have an adequate marrow function (defined as white blood cells greater than 1.5 x 103/µl (or 1,500 cells/mm3) and platelets greater than 150,000 cells/mm3; these results can be within last 60 days from the day of signing informed consent
Exclusion Criteria:
The patient cannot:
* Be less than18 years of age
* Unable to give informed consent
* Have a history of muscle invasive bladder cancer
* Be self-reported to be immune-compromised (HIV, chronic immunomodulators, chronic corticosteroids)
* Have a history of tuberculosis and/or received BCG Percutaneous Vaccination
* Pregnant or planning to become pregnant.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02326168
Study Brief:
Protocol Section:
NCT02326168