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 @ 2:48 AM
Ignite Modification Date:
2025-12-25 @ 2:48 AM
NCT ID:
NCT06396533
Eligibility Criteria:
Inclusion Criteria:
1. Properly counselled patients with high grade T1 disease who elect for cystectomy
2. Properly counselled patients with non-muscle invasive high grade Ta urothelial carcinoma or carcinoma in situ who are unresponsive to intravesical therapy and have elected cystectomy
3. cT2-T3 muscle invasive urothelial carcinoma for planned cystectomy
4. Patient who have received prior intravesical therapy or multiple TURBTs can be enrolled (data regarding number of previous TURBTs and type of intravesical therapy will be collected).
5. Male or female patients age \>=18 years at the time of consent.
6. Able and willing to comply with study requirements.
7. Patients must have a non-contrast phase component for CT scans of chest/abdomen/pelvis either pre-existing (prior to accrual) or obtained during the screening process.
8. Patients who undergo neoadjuvant systemic therapy for muscle invasive disease must be enrolled before starting systemic therapy.
9. Ability to understand and willingness to sign a written informed consent and HIPAA authorization document.
Exclusion Criteria:
1. Patients who undergo cystectomy with non-curative intent will be excluded.
2. Patients who have undergone previous definitive pelvic radiation for the purpose of treating bladder malignancy.
3. Patients who are pregnant or nursing.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06396533
Study Brief:
Protocol Section:
NCT06396533