Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDER

NCT05945108 | Completed

• 1 other identifier: D133HR00023
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 5

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).

Conditions

Urothelial Carcinoma; Non Muscle Invasive Bladder Cancer; Muscle-invasive Bladder Cancer

Keywords

Bladder Cancer, RWE

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• AstraZeneca: lead
• Hospital Israelita Albert Einstein: collaborator

Study Sites (5)

Research Site

Belo Horizonte, Brazil

Location

Research Site

Porto Alegre, Brazil

Location

Research Site

Recife, Brazil

Location

Research Site

Salvador, Brazil

Location

Research Site

São Paulo, Brazil

Location

Related Links

• Redacted CSR Synopsis

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Fernando Maluf, MD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 14, 2023
• Study Start: July 10, 2023
• Primary Completion: April 18, 2024
• Study Completion: April 18, 2024
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

BR (5)