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 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT05792033
Eligibility Criteria:
Inclusion criteria
Subjects must meet all the following inclusion criteria to participate in this study:
* Pathologically confirmed diagnosis of primary T1 bladder cancer
* Diagnosis of primary T1 bladder cancer is confirmed at 2nd look TURB
* Imaging examinations shows no lymph node metastasis or distant metastasis
* Patients who agree to surgery, and will be effected to the standard postoperative management and follow-up treatment in accordance to current guidelines
* In case of persistent T1 bladder cancer at 2nd look TURB, patient can be included only if detrusor muscle is present in the pathologic specimen
Exclusion criteria
* Previous bladder cancer
* Upstaging to MIBC at 2nd look TURB
* Contraindications to surgery (i.e. bladder fibrosis)
* Poor performance status making a surgical intervention too risky
* Life expectancy of less than one year
* Patient refused to participate
* Pregnancy
* Concomitant or history of upper urinary tract urothelial cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT05792033
Study Brief:
Protocol Section:
NCT05792033