Have you or your loved ones been diagnosed with non-muscle invasive bladder cancer?

You may be eligible to participate in a non-muscle invasive bladder cancer clinical trial.

Have you or your loved ones been diagnosed with non-muscle invasive bladder cancer? You may be eligible to participate in a non-muscle invasive bladder cancer clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Non-muscle Invasive Bladder Cancer Clinical Trial in Rouen

NCT02075060 | Phase 2 | Interventional

Have you or your loved ones been diagnosed with non-muscle invasive bladder cancer?

You may be eligible to participate in a non-muscle invasive bladder cancer clinical trial.

Have you or your loved ones been diagnosed with non-muscle invasive bladder cancer? You may be eligible to participate in a non-muscle invasive bladder cancer clinical trial.

Recruiting

Male & Female

18 Years +

This study is looking to recruit 54 Participants

The aim of this pilot study is to assess the efficacy and toxicity of immediate pre-operative instillation of mitomycin C compared to the standard early post-operative .

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Details for the study

Brief Title

Evaluation of Immediate Preoperative Instillation (IPOI) of Mitomycin C Compared to Early Postoperative Instillation (IPOP) in Non-muscle Invasive Bladder Cancer

Official Title

Brief Summary

The aim of this pilot study is to assess the efficacy and toxicity of immediate pre-operative<br /> instillation of mitomycin C compared to the standard early post-operative .

Study 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).