Brazilian Reality of Hepatocellular Carcinoma
BRA-HEP
2 other identifiers
observational
300
1 country
11
Brief Summary
National, multicenter, retrospective, non-randomized observational study (Real World Evidence-RWE) with the purpose of analyzing the epidemiological profile of Hepatocellular Carcinomas (BCLC A, B or C), clinical management, progression profile and overall survival of castrated patients treated in national oncology care reference centers, within the last 6 years (between 2017 to 2022).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2024
Shorter than P25 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2023
CompletedFirst Posted
Study publicly available on registry
January 30, 2024
CompletedStudy Start
First participant enrolled
April 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2024
CompletedSeptember 29, 2025
September 1, 2025
7 months
December 22, 2023
September 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Epidemiological profile and pathological staging
Identify the epidemiological profile and pathological staging of patients diagnosed with hepatocellular carcinoma treated at participating centers. Describe the treatments adopted and the response to the progression or non-progression of the disease.
At first diagnosis and over 6 years (Time of retrospective observational analysis of the study)
Secondary Outcomes (1)
Description of clinical condition
At first diagnosis and over 6 years (Time of retrospective observational analysis of the study)
Study Arms (2)
Cohort 1
Patients with early tumors at diagnosis (BCLC 0, A or B)
Cohort 2
Pacientes com tumores avançados ao diagnóstico (BCLC C ou D)
Eligibility Criteria
Participants with a hepatocellular carcinoma diagnosis (early and intermediate), meeting the eligibility criteria, who have had a 1st time visit to the study sites between 2017 and 2022, and with at least 2 visits with accessible information in the medical record will be included.
You may qualify if:
- Male and female;
- Above 18 years old;
- Hepatocellular carcinoma diagnosis (confirmed by biopsy or imaging);
You may not qualify if:
- Fibrollamelar carcinoma, hepatoblastoma, intrahepatic cholangiocarcinoma, neuroendocrine tumors or other less common types of liver tumors;
- Patients with incomplete staging data;
- Patients with only 1 visit to the participating site healthcare service, with loss to follow-up prior to the second visit to the participating site healthcare service;
- Previous treatment for hepatocellular carcinoma in another institution;
- Treatment with investigational drugs in a clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Hospital Israelita Albert Einsteincollaborator
Study Sites (11)
Research Site
Barretos, Brazil
Research Site
Belo Horizonte, Brazil
Research Site
Curitiba, Brazil
Research Site
Natal, Brazil
Research Site
Porto Alegre, Brazil
Research Site
Recife, Brazil
Research Site
Rio de Janeiro, Brazil
Research Site
Salvador, Brazil
Research Site
São Bernardo do Campo, Brazil
Research Site
São Paulo, Brazil
Research Site
Vitória, Brazil
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diogo Bugano
Hospital Israelita Albert Einstein
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2023
First Posted
January 30, 2024
Study Start
April 15, 2024
Primary Completion
November 14, 2024
Study Completion
November 14, 2024
Last Updated
September 29, 2025
Record last verified: 2025-09
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.
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.