BridgeMD
CLINICAL TRIAL TO EVALUATE BLADDER INSTILLATION OF NEOADJUVANT CHEMOTHERAPY TO TRANSURETHRAL RESECTION OF THE BLADDER FOR THE PREVENTION OF RECURRENCE OF NON-MUSCLE INVASIVE UROTHELIAL CARCINOMA
EU CTIS ID: 2024-512683-53-00
What this study is testing
Evaluation of the rate of early recurrences of CVNMI comparing intravesical instillation of neoadjuvant chemotherapy to TURBT with conventional TURBT without neoadjuvant chemotherapy.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients of both sexes aged ≥ 18 years.
- Patients with clinical and/or imaging evidence of CVNMI with indication for TURBT.
- Patients with a history of stage CVNMI: Ta/T1, G1-G3, without concomitant CIS (Carcinoma in situ), provided they have a disease-free period of at least 6 months.
- Karnofsky scale score > 70%.
- Patients who agree to participate in the study by signing the informed consent.
- Patients with tumors <3 cm.
You likely can't join if
- Tumors of solid or muscle invasive appearance on cystoscopy and/or preoperative imaging tests.
- Pregnant patients.
- Patients in whom it is foreseen that follow-up is not going to be possible for any reason.
- Patients who for any reason should not be included in the study according to the evaluation of the research team.
- Patients with a history of allergy to Mitomycin C, Epirubicin, Adriamycin, Cisplatin, Gemcitabine, Docetaxel.
- Patients with severe urethral stricture or inability to catheterize the bladder for any other reason prior to TURBT.
See the full eligibility criteria
- Patients of both sexes aged ≥ 18 years.
- Patients with clinical and/or imaging evidence of CVNMI with indication for TURBT.
- Patients with a history of stage CVNMI: Ta/T1, G1-G3, without concomitant CIS (Carcinoma in situ), provided they have a disease-free period of at least 6 months.
- Karnofsky scale score > 70%.
- Patients who agree to participate in the study by signing the informed consent.
- Patients with tumors <3 cm.
- Tumors of solid or muscle invasive appearance on cystoscopy and/or preoperative imaging tests.
- Pregnant patients.
- Patients in whom it is foreseen that follow-up is not going to be possible for any reason.
- Patients who for any reason should not be included in the study according to the evaluation of the research team.
- Patients with a history of allergy to Mitomycin C, Epirubicin, Adriamycin, Cisplatin, Gemcitabine, Docetaxel.
- Patients with severe urethral stricture or inability to catheterize the bladder for any other reason prior to TURBT.
- Patients will be excluded from the clinical trial if, after TURBT, their pathological anatomy report shows a diagnosis other than papillary type IMIBC (CIS only, benign lesions, muscle invasive bladder carcinoma, etc.).
- Patients with tumors ≥ 3 cm will not be included.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.