CHronic Hepatopathies Associated with ALcohol Consumption and MetAbolic Syndrome

NCT ID: NCT05623150

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 710 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-06
• Study Completion Date: 2032-03-31

Brief Summary

The aim is to determine the metabolic factors, host immune factors, and medical imaging data associated with the development of HepatoCellular Carcinoma (HCC) in patients with alcohol-related liver disease or dysmetabolic steatosis/Non-Alcoholic SteatoHepatitis.

The investigators will include patients with and without cirrhosis in order to identify early molecular mechanisms involved in the development of HCC especially in non-cirrhotic patients.

Detailed Description

Type and methodology of the research:

Within the framework of the usual management of the patient's pathology, a clinico-biological characterization (dietary and physical activity questionnaires, "performans status", anthropometric measurements, usual blood biology characterizing the hepatic, renal and inflammatory function, the carbohydrate and lipid metabolism, the non invasive test for liver fibrosis ELF etc.) will be carry out. In order to collect radiomic data, liver imaging (particularly in case of HCC) will be done.

A liver biopsy and constitution of a biobank (samples of plasma, sera, DNA and leucocyte pellets) will be performed.

The elements necessary for the classification of possible hepatocellular carcinomas (BCLC classification) will be collected.

Anticipated research schedule:

• The duration of inclusion in this research will be 10 years.
• The duration of the patient's participation will be from 1 day (if the consent is signed and the biopsy is performed on the same day) to 2 months (maximum reflection period is 8 weeks between the signature of the consent and the taking of samples).
• The total duration of the research (from the first inclusion, to the last visit of the last participant) will be 10 years and 2 months.

Conditions

Non-Alcoholic Fatty Liver Disease; Non-Alcoholic Steatohepatitis; Alcohol-related Liver Disease; Cirrhosis, Liver; Hepatocellular Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Descriptive study

The patients included in this observational study are patients with hepatic steatosis either related to NAFLD or to alcohol-related liver disease.

Patients included in the study may have hepatocellular carcinoma.

Thus, 4 groups of patients can be recruited:

• patients with NAFLD without hepatocellular carcinoma,
• patients with NAFLD with hepatocellular carcinoma,
• patients with alcohol-related liver disease without hepatocellular carcinoma, -patients with alcohol-related liver disease with hepatocellular carcinoma.

Liver biopsy

Intervention Type: DIAGNOSTIC_TEST

Liver biopsy planned as part of routine care. Clinical-biological characterisation with bio collections.

Interventions

Liver biopsy

Liver biopsy planned as part of routine care. Clinical-biological characterisation with bio collections.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Criteria common to all patients:

1. Affiliation to French social security.

2. Male or female ≥ 18 years of age

3. Patients able to receive and understand information about the research and to give written informed consent duly signed by the patient and the investigator (at the latest on the day of inclusion and before any examination necessary for the research).

• Patients in the NAFLD group with HCC:

1. Alcohol consumption ≤ 30 g pure alcohol/d (or 210 g pure alcohol/week) for men and ≤ 20 g pure alcohol/d (140 g pure alcohol/week) for women.

2. Decision, less than 3 months old, of liver biopsy of the suspected HCC nodule and non-tumour liver tissue performed as a clinical routine.

3. No systemic treatment for HCC within 6 months prior to inclusion.

• Patients in the NAFLD group without HCC:

1. Alcohol consumption ≤ 30 g pure alcohol/d (or 210 g pure alcohol/week) for men and ≤ 20 g pure alcohol/d (140 g pure alcohol/week) for women.

2. Decision of less than 3 months of a liver biopsy performed as a clinical routine. Biopsy will be motivated by liver function disturbance(s) and/or ultrasound steatosis given the lack of validated non-invasive tests or the lack of accuracy (grey areas) of available non-invasive tests for the diagnosis of necro-inflammation and/or fibrosis in some of these patients.

• Patients in the alcohol-related liver disease group with HCC:

1. Alcohol consumption > 30 g pure alcohol/d (or 210 g pure alcohol/week) for men and > 20 g pure alcohol/d (140 g pure alcohol/week) or binge drinking

2. Decision within 3 months of liver biopsy of suspected HCC nodule and non-tumour liver tissue performed as part of clinical routine

3. No systemic treatment for HCC within 6 months prior to inclusion.

• Patients in the alcohol-related liver disease group without HCC:

1. Alcohol consumption > 30 g pure alcohol/d (or 210 g pure alcohol/week) for men and > 20 g pure alcohol/d (140 g pure alcohol/week) or binge drinking

2. Decision of less than 3 months for a liver biopsy to be performed as a clinical routine. Biopsy will be motivated by liver balance disturbance(s) and/or ultrasound steatosis given the lack of validated non-invasive tests or the lack of accuracy (grey areas) of available non-invasive tests for the diagnosis of necro-inflammation and/or fibrosis in some of these patients.

Exclusion Criteria

1. Positive HIV serology

2. Patients with detectable hepatitis C viral load

3. Presence of Hbs antigen

4. History of autoimmune hepatitis type 1 or 2, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, genetic haemochromatosis homozygous, alpha1 anti-trypsin deficiency

5. Long-term use of methotrexate, corticosteroids, anti-Tumor Necrosis Factor cyclosporine, tacrolimus

6. History of solid organ transplantation or bone marrow transplantation

7. Cancerous disease in the process of being treated, except for skin cancer (excluding melanoma)

8. Patients under legal protection or unable to express their consent,

9. Pregnant or breastfeeding women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Batiment Archimed 151, route de Saint Antoine de Ginestière

Nice, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Rodolphe Anty, MD, PhD

Role: CONTACT

anty.r@chu-nice.fr

0033492035943

Other Identifiers

C20-12

Identifier Type: -

Identifier Source: org_study_id