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 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT02252393
Eligibility Criteria:
Inclusion Criteria:
* Grade G1 - G3 bladder cancer
* T stage: cTis - T2
* N0
* M0
* American Society of Anesthesiologists (ASA) \< 4
* Informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status 2 or better
* Hemoglobin (Hgb) \> 8.0 g/dL
* White blood cell (WBC) \> 2.0 k/uL
* Platelets \> 50,000
* Creatinine \< 3.0 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) \< 5.0 x ULN
* Alanine transaminase (ALT) \< 5.0 x ULN
Exclusion Criteria:
* Patient unsuitable for or refusing radical cystectomy
* T stage ≥ T3 (mass extending outside the bladder)
* Gross nodal or metastatic disease at presentation (≥ N1, M1)
* Prior pelvic radiation
* Prior open or laparoscopic/robotic bladder or prostate surgery
* Prior colorectal surgery or history of inflammatory bowel disease
* Body mass index (BMI) ≥ 40
* ECOG performance status 3 or worse
* History of coagulopathy or bleeding disorders
* Chronic steroid use
* Patients with end stage renal disease (ESRD) and/or on dialysis
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02252393
Study Brief:
Protocol Section:
NCT02252393