Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDER

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

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).

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Brazil
  • Belo Horizonte, Brazil
    • Research Site
  • Porto Alegre, Brazil
    • Research Site
  • Recife, Brazil
    • Research Site
  • Salvador, Brazil
    • Research Site
  • Sao Paulo, Brazil
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Subjects to be enrolled are those with early urothelial carcinoma (high-risk non-muscle invasive and localized muscle-invasive), who meet the eligibility criteria and have been treated and followed in study participating sites within the last 6 years (period from 2017 to 2022).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Hospital Israelita Albert Einstein
• Investigators: Principal Investigator: Fernando Maluf, MD, Hospital Israelita Albert Einstein

Publications and helpful links

Helpful Links

• Redacted CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Actual): April 18, 2024
• Study Completion (Actual): April 18, 2024

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Bladder Cancer, RWE
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms
• Other Study ID Numbers: D133HR00023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No