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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT03636256
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent;
* Age ≥18 years;
* Patients with either:
* High-risk Non-Muscle Invasive Bladder Cancer (NMIBC);
* Muscle Invasive Bladder Cancer (MIBC);
* Urothelial carcinoma confirmed by biopsy, urine cytology, computed tomography scan (CT) or other institution-approved diagnostic methodology;
* All visible tumors removed during bladder resection (TURBT);
* Performance Status (ECOG) 0-2 at study entry;
* Life expectancy of at least 6 months;
* Adequate marrow, liver, and renal function;
* ANC ≥ 1.5 x 10\^9/L;
* Hemoglobin ≥ 9.5 grams/dL;
* Platelets ≥ 75 x 10\^9/L;
* Total bilirubin ≤ 1.5x institutional ULN;
* AST/ ALT ≤ 2.5x institutional ULN;
* Creatinine ≤ 1.5x institutional ULN;
* Adequate method of birth control.
Exclusion Criteria:
* Metastatic disease;
* Previous (within 12 months) or concurrent history of non-bladder malignancy, except for non-melanoma skin cancer;
* Intravesical therapy within 6 weeks prior to consent (chemotherapy or immunotherapy including BCG administered directly into the bladder);
* Resection surface area greater than 8 cm2;
* Upper tract and urethral disease within 18 months;
* Known hypersensitivity to any of the study drug components or reconstitution components;
* Pregnant or breastfeeding;
* Participation in the treatment phase of another clinical trial within 3 months prior to consent;
* Investigator's opinion of subject's probable noncompliance or inability to understand the trial and/or give adequate informed consent;
* Ongoing drug or alcohol abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03636256
Study Brief:
Protocol Section:
NCT03636256