CHronic Hepatopathies Associated With ALcohol Consumption aNd metAbolic Syndrome

NCT05623150 | Recruiting

• 1 other identifier: C20-12
• Study Type: observational
• Target: 710
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Primary outcome measure CHALNA2

  The primary endpoint will be the study of variations in metabolic gene markers (i.e. mRNA of genes implicated in inflammation or metabolism assessed in qPCR, using a housekeeping gene such as glyceraldehyde-3-phosphate dehydrogenase (GAPDH)), in patients with and without hepatocellular carcinoma with different levels of severity of liver damage.

  2022-2032

Secondary Outcomes (6)

• Secondary outcome measure CHALNA2

  2022-2032

• 3th outcome measure CHALNA2

  2022-2032

• 4th outcome measure CHALNA2

  2022-2032

• 5th outcome measure CHALNA2

  2022-2032

• 6th outcome measure CHALNA2

  2022-2032

Study Arms (1)

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.

Diagnostic Test: Liver biopsy

Interventions

Liver biopsy DIAGNOSTIC_TEST

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

Descriptive study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Criteria common to all patients:
• Affiliation to French social security.
• Male or female ≥ 18 years of age
• Patients in the NAFLD group with HCC:
• 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.
• Decision, less than 3 months old, of liver biopsy of the suspected HCC nodule and non-tumour liver tissue performed as a clinical routine.
• Patients in the NAFLD group without HCC:
• 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.
• 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:
• 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
• Decision within 3 months of liver biopsy of suspected HCC nodule and non-tumour liver tissue performed as part of clinical routine
• Patients in the alcohol-related liver disease group without HCC:
• 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
• 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.

You may not qualify if:

• Positive HIV serology
• Patients with detectable hepatitis C viral load
• Presence of Hbs antigen
• History of autoimmune hepatitis type 1 or 2, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, genetic haemochromatosis homozygous, alpha1 anti-trypsin deficiency
• Long-term use of methotrexate, corticosteroids, anti-Tumor Necrosis Factor cyclosporine, tacrolimus
• History of solid organ transplantation or bone marrow transplantation
• Cancerous disease in the process of being treated, except for skin cancer (excluding melanoma)
• Patients under legal protection or unable to express their consent,
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• Centre Hospitalier Universitaire de Nice: collaborator

Study Sites (1)

Batiment Archimed 151, route de Saint Antoine de Ginestière

Nice, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

standard liver biopsy (for immunocytochemistry), frozen liver biopsy, frozen serum, frozen plasma, DNA

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Central Study Contacts

Rodolphe Anty, MD, PhD

CONTACT

0033492035943; anty.r@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: November 21, 2022
• Study Start: December 6, 2022
• Primary Completion (Estimated): January 1, 2032
• Study Completion (Estimated): March 1, 2032
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)