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 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT01939756
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older
* Complete transurethral resection of primary histologically proven high risk urothelial non-muscle invasive bladder tumors: high grade (G3,) stage pTa, pT1, and carcinoma in situ (pTis
* Intravesical BCG treatment
* Adequate bone marrow reserve (ie, white-blood-cell count ≥4000 x106 cells/L and platelet count
≥120 x 109/L
* Normal renal function (function (ie, serum creatinine ≤123•76 µmol/L)
* normal liver function ((ie, serum glutamic-oxaloacetic transaminase ≤42 U/L, serum glutamic-pyruvic transaminase ≤48 U/L, and total bilirubin ≤22•23 µmol/L)
* Karnofsky performance score of 50 to 100
Exclusion Criteria:
* Previous intravesical treatment with chemotherapeutic and immunotherapeutic drugs
* Previous or concomitant urothelial carcinoma of the upper urinary tract and urethra, or both
* Previous muscle-invasive (ie, stage T2 or higher) urothelia carcinoma of the bladder
* Known allergy to baobab oil
* Bladder capacity less than 200 mL
* Untreated urinary-tract infection
* Severe systemic infection (ie, sepsis)
* Urethral strictures that would prevent endoscopic procedures and catheterisation
* Disease of upper urinary tract (eg, vesicoureteral reflux or urinary-tract stones) that would make multiple transurethral procedures at risk
* Previous radiotherapy to the pelvis;
* Other concurrent chemotherapy;
* Treatment with radiotherapy-response or biological-response modifiers;
* Other malignant diseases within 5 years of trial registration (except for basal-cell carcinoma);
* Pregnancy or nursing;
* Psychological, familial, sociological, or geographical factors that would preclude study participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01939756
Study Brief:
Protocol Section:
NCT01939756