Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDER

Completed

• Conditions: Muscle-invasive Bladder Cancer; Non Muscle Invasive Bladder Cancer; Urothelial Carcinoma

• Registration Number: NCT05945108
• Lead Sponsor: AstraZeneca

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).

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 Timeline

• Study First Submitted: 2023-06-22
• Study Start: 2023-07-10
• Study First Submitted QC: 2023-07-11
• Study First Posted: 2023-07-14
• Primary Completion: 2024-04-18
• Study Completion: 2024-04-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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);

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇧🇷 Sao Paulo, Brazil