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Studying liver damage from alcohol and fatty liver to understand liver cancer risk

Observes adults with fatty or alcohol-related liver disease to learn what leads to liver cancer.

Plain-language title generated from the registry record
Registry title: CHronic Hepatopathies Associated With ALcohol Consumption aNd metAbolic Syndrome

Key facts

Where
Nice, FranceSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with fatty liver disease linked to metabolic problems, or liver disease linked to alcohol. Some have liver cancer (HCC) and some do not. A liver biopsy is planned as part of routine care.

Age
18 years or older
Sex
Men and women can join.
Disease stage
Fatty liver disease (NAFLD) or alcohol-related liver disease, with or without liver cancer (HCC), with or without cirrhosis. A liver biopsy decision made less than 3 months ago.
Earlier treatment
For people with HCC: no systemic treatment for HCC in the 6 months before joining.

Main reasons for not taking part

  • Positive HIV test
  • Detectable hepatitis C virus or Hbs antigen present
  • Other liver diseases such as autoimmune hepatitis, primary biliary cholangitis or Wilson's disease
  • History of solid organ or bone marrow transplant
  • Pregnant or breastfeeding women

Read by machine on 12 November 2026.

Where in France

  • Batiment Archimed 151, route de Saint Antoine de GinestièreNice, FranceContact: Rodolphe Anty, MD, PhDTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Institut National de la Santé Et de la Recherche Médicale, France
Trial code
NCT05623150
Record updated
16 April 2026
Original description
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.Read full original descriptionShow less

CHronic Hepatopathies Associated With ALcohol Consumption aNd metAbolic Syndrome

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.

Inclusion: Criteria common to all patients:; Affiliation to French social security; Male or female ≥ 18 years of age; 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:; 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; No systemic treatment for HCC within 6 months prior to inclusion; 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; No systemic treatment for HCC within 6 months prior to inclusion; 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.

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

ClinicalTrials.gov NCT05623150