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 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT03664869
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven non-muscle-invasive tumour types confined to the urinary bladder
* Carcinoma in situ with or without a papillary tumour(s)
* Ta tumour(s) of high-grade
* Any T1 tumour(s)
* Written informed consent is required from every eligible patient
* Second resection performed in case of T1 tumour
* Adequate physical and mental condition to participate in the study (as judged by treating physician
Exclusion Criteria:
* Ta low grade tumour(s)
* Muscle invasive (pT≥2) tumors
* Urothelial cancer involving the prostatic urethra or upper urinary tract
* Non-urothelial bladder cancer.
* Prior BCG failure (If the patient has previously been successfully treated with BCG, and duration from the last instillation is \>12 months, participation may be considered, if bladder preserving is chosen)
* Prior or concurrent immunotherapy
* Any medication or condition considered as contraindication to BCG or MMC (as judged by the treating physician)
* Urethral stricture, stone disease, chronic urinary tract infection or any other urological condition that may comprise study participation (as judged by the treating physician)
* Known allergy to MMC or BCG
* Age \< 18 years
* Pregnancy or lactating patient
* Other untreated or unstable malignancy in risk of recurrence/progression (as judged by the treating physician)
* Cardiac pacemaker
* Expected survival time less than one year
* Expected poor compliance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03664869
Study Brief:
Protocol Section:
NCT03664869