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Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis
EU CTIS ID: 2024-519288-17-00
What this study is testing
Assessment of progression-free survival in patients diagnosed with high-risk non-muscle infiltrating bladder tumours (NMIBT) treated with adjuvant IMUNO BCG Moreau RJ.
- Therapeutic exploratory (Phase II)
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
- Signature of the informed consent before any activity related to the study, including the necessary evaluations for the selection
- Age between 18 and 85 years at the time of signing the informed consent.
- Urothelial tumor
- High risk non-muscle invasive bladder tumor (defined as Ta-T1 and GIIb or GIII) diagnosed de novo or relapsed with or without associated in situ carcinoma. or carcinoma in situ isolated without visible tumor.
- Patient with risk of recurrence or progression greater than or equal to 7 points, according to CUETO tables
You likely can't join if
- No muscle layer in pathological examination piece's
- Woman considered potentially fertile. Following the Clinical Trial Facilitation Group (CTFG) recommendations, a woman is considered childbearing potential (WOCBP), following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- Patients with difficulties to perform the follow-up visits established in the protocol.
- Non-urothelial tumor
- Active cancer in any other location
- Diagnosis of any other pathology that in the opinion of the researcher may increase the risk of the subject or reduce the chances of obtaining satisfactory data to achieve the objectives of the study, including the consumption of alcohol or any other drug.
See the full eligibility criteria
- Signature of the informed consent before any activity related to the study, including the necessary evaluations for the selection
- Age between 18 and 85 years at the time of signing the informed consent.
- Urothelial tumor
- High risk non-muscle invasive bladder tumor (defined as Ta-T1 and GIIb or GIII) diagnosed de novo or relapsed with or without associated in situ carcinoma. or carcinoma in situ isolated without visible tumor.
- Patient with risk of recurrence or progression greater than or equal to 7 points, according to CUETO tables
- No muscle layer in pathological examination piece's
- Woman considered potentially fertile. Following the Clinical Trial Facilitation Group (CTFG) recommendations, a woman is considered childbearing potential (WOCBP), following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- Patients with difficulties to perform the follow-up visits established in the protocol.
- Non-urothelial tumor
- Active cancer in any other location
- Diagnosis of any other pathology that in the opinion of the researcher may increase the risk of the subject or reduce the chances of obtaining satisfactory data to achieve the objectives of the study, including the consumption of alcohol or any other drug.
- Administration of BCG in the last year before signing the informed consent.
- BCG first instillation contraindication during more than 15 days for any cause such as low bladder capacity, urinary infection, hematuria, etc
- Impossibility of performing a second transurethral resection (ReRTU) between 4 and 8 weeks after the first.
- Inability to start treatment within the first 4 weeks after the second transurethral resection (ReRTU)
- Participation in another clinical study where they received a research drug in the 6 months prior to signing the informed consent
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, 65+ years, 18-64 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.