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 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT07204132
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18 and 85 years old, gender not restricted;
2. Clinically diagnosed as patients with bladder tumors, and classified as high-risk non-muscle-invasive bladder cancer through biopsy or TURBT staging.
\* High-risk non-muscle bladder cancer is defined as meeting any of the following criteria: ① T1 stage tumor; ② High-grade urothelial carcinoma; ③ Simultaneously meeting: multiple, recurrent and diameter \> 3cm bladder cancer;
3. The number of tumors is no more than 5;
4. Have the intention to preserve the bladder;
5. Voluntarily sign the informed consent form and be able to cooperate throughout the trial.
Exclusion Criteria:
1. Preoperative imaging indicated involvement of organs around the bladder (such as ureters, prostate, rectum, etc.), the pelvic or abdominal wall, or lymph node metastasis (N1) and distant metastasis (M1) stage;
2. Preoperative imaging indicated hydronephrosis, pathology suggested carcinoma in situ or diagnostic TURBT indicated diffuse tumor growth during the procedure;
3. Known to be allergic to chemotherapy drugs and/or immunotherapy drugs;
4. Complicated with severe infectious diseases such as bacteremia and toxemia;
5. Complicated with severe coagulation dysfunction;
6. Suffering from serious diseases such as heart, brain, lung, liver, kidney, etc., and unable to tolerate surgery;
7. Suffering from other malignant tumors;
8. Pregnant or lactating women;
9. Complicated with severe complications such as urethral stenosis that cannot tolerate cystoscopy surgery;
10. Complicated with prohibited medications, including systemic anti-tumor drugs and immunosuppressants;
11. Participating in other clinical trials simultaneously;
12. Other situations that the investigator considers inappropriate for participating in this clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT07204132
Study Brief:
Protocol Section:
NCT07204132