Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis
Key facts
- Where
- A Coruña, Bilbao, Cadiz, Córdoba, Granada, Jaén, Jerez de la Frontera, Madrid, Majadahonda, Málaga, Oviedo és Valladolid, SpanyolországSee the 15 sites
- Phase
- 2. fázis
Where in Spanyolország
- Complexo Hospitalario Universitario A CoruñaA Coruña, SpanyolországNo longer taking part
- Hospital Universitario BasurtoBilbao, SpanyolországNo longer taking part
- Hospital Universitario Puerta del MarCadiz, SpanyolországNo longer taking part
- Hospital Universitario Reina SofiaCórdoba, SpanyolországNo longer taking part
- Hospital Universitario Virgen de las NievesGranada, SpanyolországNo longer taking part
- Hospital Universitario de JaénJaén, SpanyolországNo longer taking part
- Hospital de Jerez de la FronteraJerez de la Frontera, SpanyolországNo longer taking part
- Clinica Universidad de NavarraMadrid, SpanyolországNo longer taking part
- Hospital Universitario 12 de OctubreMadrid, SpanyolországNo longer taking part
- Hospital Universitario Fundación Jiménez DíazMadrid, SpanyolországNo longer taking part
- Hospital Universitario La PazMadrid, SpanyolországNo longer taking part
- Hospital Universitario Puerta de Hierro de MajadahondaMajadahonda, SpanyolországNo longer taking part
- Hospital Universitario Regional de MálagaMálaga, SpanyolországNo longer taking part
- Hospital Universitario Central De AsturiasOviedo, SpanyolországNo longer taking part
- Hospital Clínico Universitario de ValladolidValladolid, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Biofabri S.L.
- Trial code
- EU 2024-519288-17-00
- Record updated
- 2026. április 30.
- Original description
Assessment of progression-free survival in patients diagnosed with high-risk non-muscle infiltrating bladder tumours (NMIBT) treated with adjuvant IMUNO BCG Moreau RJ.Read full original descriptionShow less
Assessment of progression-free survival in patients diagnosed with high-risk non-muscle infiltrating bladder tumours (NMIBT) treated with adjuvant IMUNO BCG Moreau RJ.
Inclusion: 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.
Exclusion: 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; 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; Active cancer in any other location; BCG first instillation contraindication during more than 15 days for any cause such as low bladder capacity, urinary infection, hematuria, etc; 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; Administration of BCG in the last year before signing the informed consent.