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 @ 9:55 PM
Ignite Modification Date:
2025-12-24 @ 9:55 PM
NCT ID:
NCT02968732
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients age \>18 years at the time of consent.
2. Patients with a diagnosis of urothelial carcinoma clinical stage T1-T4NanyM0.
3. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
4. Patients must have a clinical decision to proceed with radical cystectomy by any conventional approach (open, laparoscopic, robot-assisted laparoscopic). Time from decision to surgery is usually 3-8 weeks for those who do not receive neoadjuvant chemotherapy and 10-14 weeks for those who receive neo-adjuvant chemotherapy treatment. During this time, eligibility for study participation will be verified.
5. Ability to understand and willingness to sign a written informed consent and HIPAA authorization document or a legally authorized representative who has the ability to understand and willingness to sign a written informed consent and HIPAA authorization on behalf of the participant.
6. Women of reproductive potential must have agreed to use an effective contraceptive measure.
Exclusion Criteria:
1. Patients who undergo cystectomy with non-curative intent will be excluded.
2. Patients who have undergone any prior pelvic irradiation.
3. Patients who are pregnant or nursing. Radical cystectomy and prolonged general anesthesia would place the fetus at considerable risk of demise. The prolonged recovery and debility of the patient would severely limit the patient's ability to nurse and care for an infant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02968732
Study Brief:
Protocol Section:
NCT02968732