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 @ 2:26 AM
Ignite Modification Date:
2025-12-25 @ 2:26 AM
NCT ID:
NCT05024734
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Signed Informed Consent Form
* ECOG performance status of 0 or 1
* Histologically confirmed intermediate risk non muscle-invasive urothelial carcinoma of the bladder (pTa low grade) Patients
* Representative fresh tumor specimen for PDO generation and drug screen
Exclusion Criteria:
* Known previous high grade and/or high risk non muscle-invasive bladder cancer
* Previous Intravesical biological/immuno (BCG) therapy
* Pregnancy or nursing
* Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol
* Severe infection within 4 weeks prior to cycle 1, day 1
* Contraindication for frequent catheterization
* Voiding dysfunction
* Pregnancy or nursing
* Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 6 months after the last treatment.
* Male subject who is unwilling to use acceptable method of effective contraception during IP treatment and through 6 months after the last dose of IP.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05024734
Study Brief:
Protocol Section:
NCT05024734