Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDER

March 25, 2024 updated by: AstraZeneca

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

Recruiting

Conditions

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 (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • São Paulo, Brazil, 05652-900
        • Recruiting
        • Hospital Israelita Albert Einstein
        • Contact:
        • Principal Investigator:
          • Fernando Maluf, MD
        • Sub-Investigator:
          • Arie Carneiro, MD
        • Sub-Investigator:
          • André Paterno, MD
      • São Paulo, Brazil, 04378-500
        • Not yet recruiting
        • Hospital Municipal da Vila Santa Catarina
        • Contact:
        • Principal Investigator:
          • André Paterno
      • São Paulo, Brazil, 04029-001
        • Recruiting
        • Instituto de Assistência Médica do Servidor Público do Estado de São Pualo
        • Contact:
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30380-472
        • Not yet recruiting
        • Associacao Mario Penna (Nucleo de Ensino E Pesquisas Mario Penn
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50070-902
        • Recruiting
        • Instituto de Medicina Integral Professor Fernando Figueira - IMIP
        • Contact:
        • Principal Investigator:
          • Andrea Lopes
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-001
        • Recruiting
        • Hospital Moinhos de Vento - HMV
        • Contact:
        • Principal Investigator:
          • Eduardo Carvalhal
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
        • Recruiting
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre - ISCMPA
        • Contact:
        • Principal Investigator:
          • Bruna Motke
    • Salvador
      • Rio Vermelho, Salvador, Brazil, 41950-640
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil, 88034-000
        • Not yet recruiting
        • Centro de Pesquisas Oncológicas - CEPON
        • Contact:
        • Principal Investigator:
          • Fabricio Pontes Granado
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Recruiting
        • Fundacao Faculdade Regional de Medicina S J Rio Preto - Cip
        • Contact:
        • Principal Investigator:
          • João Antonio Soler

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
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.
At first diagnosis and over 6 years (Time of retrospective observational analysis of the study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Hospital Israelita Albert Einstein

Investigators

  • Principal Investigator: Fernando Maluf, MD, Hospital Israelita Albert Einstein

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2023

Primary Completion (Estimated)

July 30, 2024

Study Completion (Estimated)

July 30, 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)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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