Skip to main content
OpenTrials
Completed

NCT Number: NCT05945108

Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDER

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).

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

Primary outcomes

  1. Clinical staging

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Hospital Israelita Albert Einstein

Registry information

Official study title

Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDER: Multicenter Retrospective Study (Real World Evidence - RWE)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 14, 2023
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.