Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDER
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Urothelial carcinoma has several histological types, extensive genetic diversity and a wide array of risk factors related to disease development. Moreover, the treatment effectiveness may be widely impacted by factors such as age, previous comorbidities, socio-economic factors, late diagnosis and access to treatment. In the last decade, the treatment profile has evolved worldwide with the incorporation of new technologies, however, there is no data on Brazilian reality in this period. In a continent-sized country and such heterogeneous health services as Brazil, preparing such knowledge becomes more important and challenging. This paper proposed to describe early urothelial carcinoma presentation pattern and treatment in Brazilian population (high-risk non-muscle-invasive and localized muscle-invasive) in several sites spread throughout the national territory. Thus, data will be generated to provide a more appropriate understanding of the current landscape and, consequently, the better design of public policies to face this disease.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Non-muscle-invasive bladder cancer or Muscle-invasive bladder cancer Defined as: T1 tumor and/or high-grade lesion (G3) and/or presence of CIS (Carcinoma in situ). Multifocal relapsed tumor and with at least one large lesion (diameter ≥ 3 cm); Or: -Diagnosis of early muscle-invasive urothelial bladder carcinoma. |
Outcome Measures
Primary Outcome Measures
- Clinical staging [at first diagnosis and over 6 years (Time of retrospective observational analysis of the study)]
Description of the characteristics of the lesions at the initial diagnosis, performed by histopathology and imaging exams.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years old;
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Diagnosis of high-risk non-muscle invasive urothelial carcinoma, defined as:
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T1 tumor and/or high-grade lesion (G3) and/or presence of CIS.
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Multifocal relapsed tumor and with at least one large lesion (diameter ≥ 3 cm);
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Diagnosis of early muscle-invasive urothelial bladder carcinoma (cT2, cT3 or cT4a N0);
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Consent to participate in the study.
Exclusion Criteria:
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Low-risk non-muscle invasive urothelial carcinoma (single lesion, pTa and low-grade);
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Locally advanced muscle-invasive urothelial carcinoma (suspected lymph node impairment in staging imaging tests) or metastatic at diagnosis;
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Bladder carcinoma with non-urothelial histology (adenocarcinoma, squamous-cell carcinoma or small cell carcinoma);
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Instituto de Medicina Integral Professor Fernando Figueira - IMIP | Recife | Pernambuco | Brazil | 50070-902 |
| 2 | Irmandade da Santa Casa de Misericórdia de Porto Alegre - ISCMPA | Porto Alegre | Rio Grande Do Sul | Brazil | 90020-090 |
| 3 | Hospital Moinhos de Vento - HMV | Porto Alegre | Rio Grande Do Sul | Brazil | 90035-001 |
| 4 | Ensino E Terapia de Inovação Clínica Amo | Rio Vermelho | Salvador | Brazil | 41950-640 |
| 5 | Centro de Pesquisas Oncológicas - CEPON | Florianópolis | Santa Catarina | Brazil | 88034-000 |
| 6 | Fundacao Faculdade Regional de Medicina S J Rio Preto - Cip | São José do Rio Preto | São Paulo | Brazil | 15090-000 |
| 7 | Hospital Israelita Albert Einstein | São Paulo | Brazil | 05652-900 |
Sponsors and Collaborators
- Hospital Israelita Albert Einstein
- AstraZeneca
Investigators
- Principal Investigator: Fernando Maluf, MD, Hospital Israelita Albert Einstein
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BRA-BLADDER