Urothelial Carcinoma Clinical Trial
Official title:
Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDER: Multicenter Retrospective Study (Real World Evidence - RWE)
NCT number | NCT05945108 |
Other study ID # | D133HR00023 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 10, 2023 |
Est. completion date | July 30, 2024 |
A national, multicenter, non-randomized, retrospective, observational study (Real-World Evidence-RWE) aimed at analyzing clinical presentation profiles and demographic characteristics of patients with early urothelial bladder cancer (high-risk non-muscle invasive and localized muscle-invasive) treated with standard therapies in national cancer treatment reference centers within the last 6 years (between 2017 and 2022).
Status | Recruiting |
Enrollment | 400 |
Est. completion date | July 30, 2024 |
Est. primary completion date | July 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Age = 18 years old; - Diagnosis of high-risk non-muscle invasive urothelial carcinoma, defined as: - T1 tumor and/or high-grade lesion (G3) and/or presence of CIS. - Multifocal relapsed tumor and with at least one large lesion (diameter = 3 cm); - Diagnosis of early muscle-invasive urothelial bladder carcinoma (cT2, cT3 or cT4a N0); - Consent to participate in the study. Exclusion Criteria: - Low-risk non-muscle invasive urothelial carcinoma (single lesion, pTa and low-grade); - Locally advanced muscle-invasive urothelial carcinoma (suspected lymph node impairment in staging imaging tests) or metastatic at diagnosis; - Bladder carcinoma with non-urothelial histology (adenocarcinoma, squamous-cell carcinoma or small cell carcinoma); |
Country | Name | City | State |
---|---|---|---|
Brazil | Associacao Mario Penna (Nucleo de Ensino E Pesquisas Mario Penn | Belo Horizonte | Minas Gerais |
Brazil | Centro de Pesquisas Oncológicas - CEPON | Florianópolis | Santa Catarina |
Brazil | Hospital Moinhos de Vento - HMV | Porto Alegre | Rio Grande Do Sul |
Brazil | Irmandade da Santa Casa de Misericórdia de Porto Alegre - ISCMPA | Porto Alegre | Rio Grande Do Sul |
Brazil | Instituto de Medicina Integral Professor Fernando Figueira - IMIP | Recife | Pernambuco |
Brazil | Ensino E Terapia de Inovação Clínica Amo | Rio Vermelho | Salvador |
Brazil | Fundacao Faculdade Regional de Medicina S J Rio Preto - Cip | São José do Rio Preto | São Paulo |
Brazil | Hospital Israelita Albert Einstein | São Paulo | |
Brazil | Hospital Municipal da Vila Santa Catarina | São Paulo | |
Brazil | Instituto de Assistência Médica do Servidor Público do Estado de São Pualo | São Paulo |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca | Hospital Israelita Albert Einstein |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical staging | Description of the characteristics of the lesions at the initial diagnosis, performed by histopathology and imaging exams. | At first diagnosis and over 6 years (Time of retrospective observational analysis of the study) |
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