Clinical trial NCT06230328: Brazilian Reality of Hepatocellular Carcinoma
Official title: Brazilian Reality of Hepatocellular Carcinoma - BRA-HEP: Multicenter Retrospective Study (Real World Evidence - RWE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Hepatocellular Carcinoma by BCLC Stage
Hepatocellular Carcinoma Stage I
Hepatocellular Carcinoma Stage II
Hepatocellular Carcinoma Stage III
Keywords: Hepatocellular carcinoma; RWE
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Hospital Israelita Albert Einstein
First posted: 2024-01-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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).

Detailed description: Hepatocellular carcinoma is the third leading cause of cancer-related deaths worldwide. Prognosis strongly depends of the underlying liver disease, tumor-specific characteristics such as tumor load, extrahepatic spread and portal vein branch thrombosis, as well as access to treatments. The Brazilian reality of hepatocellular tumor clinical presentation varies widely and the management profile, treatments adopted and response rates are little described. Taking into consideration the heterogeneity of health services in reference centers in Brazil, knowing the epidemiology profile and treatment of these tumors is of paramount importance to improve care for patients, deepen the knowledge in these diseases and foster for the generation of new regional researches. The primary objective of this study is to determine and describe the epidemiological profile of hepatocellular carcinoma BCLC (Barcelona Algorithm of Liver Cancer) stages 0, A, B and C of patients followed in Brazilian reference oncology centers, within the last 6 years (between 2017 to 2022). The secondary objective is to describe the treatment and endpoints patterns of 2 disease cohorts: early disease (BCLC 0, A and B) and advanced disease (BCLC C).

Eligibility criteria: Inclusion Criteria:

* Male and female;
* Above 18 years old;
* Hepatocellular carcinoma diagnosis (confirmed by biopsy or imaging);

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Epidemiological profile and pathological staging
timeFrame: At first diagnosis and over 6 years (Time of retrospective observational analysis of the study)
Secondary outcomes:
measure: Description of clinical condition
timeFrame: At first diagnosis and over 6 years (Time of retrospective observational analysis of the study)
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Research Site
city: Belo Horizonte
country: Brazil
facility: Research Site
city: Curitiba
country: Brazil
facility: Research Site
city: Natal
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Recife
country: Brazil
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Salvador
country: Brazil
facility: Research Site
city: Sao Bernardo do Campo
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Vitoria
country: Brazil
facility: Research Site
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Diogo Bugano
role: PRINCIPAL_INVESTIGATOR
References: