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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT02075060
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years,
* Primary or recurrent bladder tumor with endoscopic papillary aspect,
* One or two bladder tumors,
* Cytology before TURB showing no high-grade cells,
* Patients without tutorship or subordination (ou curatorship),
* Patients under the general social security system or qualifying through a third party,
* Informed consent signed by the patient after clear and fair information.
Exclusion Criteria:
* Age \< 18 years,
* Allergy to mitomycin C,
* Traumatic stenting,
* Upper tract urothelial cancer,
* Urethral invasion,
* History of muscle invasive bladder cancer,
* Extensive tumor (3 cm or more),
* Any contraindication to TURB,
* Simultaneous participation in another clinical research study,
* Patients not insured by the social security or not qualifying through a third party,
* Patients with enhanced protection, namely pregnant or lactating women, persons deprived of their liberty by a judicial or administrative decision, people staying in a health or social institution, adults under legal protection, and finally patients in emergency situations,
* Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study (i.e. hormonal / mechanical contraceptive : oral, injectable, transdermal, implantable, intrauterine or surgical device: tubal ligation, hysterectomy, total oophorectomy).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02075060
Study Brief:
Protocol Section:
NCT02075060