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 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT01920269
Eligibility Criteria:
Inclusion Criteria:
* histologically proven primary stage pTa-pT1 urothelial bladder cancer,
* adequate bone-marrow reserve (ie, white-blood-cell count ≥4000 × 10⁶ cells per L; platelet count ≥120 × 10⁹/L),
* normal renal function (ie, serum creatinine ≤123·76 μmol/L),
* normal liver function (ie, serum glutamic-oxaloacetic aminotransferase ≤42 U/L, serum glutamic-pyruvic aminotransferase ≤48 U/L, and total bilirubin ≤22 μmol/L),
* Eastern Cooperative Oncology Group performance status between 0 and 2.
Exclusion Criteria:
* non-urothelial carcinomas of the bladder;
* previous or concomitant grade G3 urothelial and/or carcinoma in situ of the bladder;
* urothelial carcinoma of the upper urinary tract and urethra, or both;
* previous intravesical treatment with chemotherapeutic and immunotherapeutic drugs;
* known allergy to mitomycin;
* bladder capacity less than 200 mL;
* untreated urinary-tract
* infection; severe systemic infection (ie, sepsis);
* treatment with immunosuppressive drugs;
* urethral strictures that would prevent endoscopic procedures and catheterisation;
* previous radiotherapy to the pelvis;
* other concurrent chemo therapy, radio therapy, and treatment with biological response modifiers;
* other malignant diseases within 5 years of trial registration (except for adequately treated basal-cell or squamous-cell skin cancer, in situ cervical cancer);
* pregnancy;
* any factors that would preclude study participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01920269
Study Brief:
Protocol Section:
NCT01920269