Actively Recruiting
CHronic Hepatopathies Associated With ALcohol Consumption and Metabolic Syndrome
Led by Institut National de la Santé Et de la Recherche Médicale, France · Updated on 2026-04-16
710
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
I
Institut National de la Santé Et de la Recherche Médicale, France
Lead Sponsor
C
Centre Hospitalier Universitaire de Nice
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the metabolic factors, immune system elements, and imaging data linked to the development of Hepatocellular Carcinoma (HCC) in patients with liver disease caused by alcohol use or metabolic issues like Non-Alcoholic Steatohepatitis (NASH). The study includes patients both with and without cirrhosis to better understand early molecular changes that may lead to HCC, especially in those without cirrhosis. This observational study involves patients categorized into four groups based on the presence of NAFLD or alcohol-related liver disease, and whether they have HCC. Participants will undergo clinical and biological assessments including dietary and physical activity questionnaires, liver function tests, and imaging studies. Liver biopsies and biological sample collections (plasma, sera, DNA, leukocytes) will be performed as part of routine care, with data collection spanning 10 years. Participants will be involved from as short as one day up to two months depending on biopsy timing. The study includes non-invasive and invasive assessments, liver imaging, and classification of liver cancer stages. Researchers will monitor various health parameters, collect biosamples for a biobank, and evaluate primary and secondary outcomes over a decade. This long-term follow-up aims to uncover mechanisms driving liver cancer development in these patient groups.
CONDITIONS
Brief Title
CHronic Hepatopathies Associated With ALcohol Consumption aNd metAbolic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Affiliated with French social security
- Male or female aged 18 years or older
- Able to understand study information and provide written informed consent
- For NAFLD patients with HCC: alcohol intake ≤30 g/day for men or ≤20 g/day for women; liver biopsy decision within last 3 months; no systemic HCC treatment within 6 months
- For NAFLD patients without HCC: alcohol intake ≤30 g/day for men or ≤20 g/day for women; liver biopsy decision within last 3 months
- For alcohol-related liver disease patients with HCC: alcohol intake >30 g/day for men or >20 g/day for women or binge drinking; liver biopsy decision within last 3 months; no systemic HCC treatment within 6 months
- For alcohol-related liver disease patients without HCC: alcohol intake >30 g/day for men or >20 g/day for women or binge drinking; liver biopsy decision within last 3 months
You will not qualify if you...
- Positive HIV test
- Detectable hepatitis C viral load
- Presence of hepatitis B surface antigen
- History of autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, genetic haemochromatosis homozygous, or alpha1 anti-trypsin deficiency
- Long-term use of methotrexate, corticosteroids, anti-TNF agents, cyclosporine, or tacrolimus
- History of solid organ or bone marrow transplant
- Active cancer treatment except for non-melanoma skin cancer
- Under legal protection or unable to consent
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 months between consent and sample collection
Participants undergo clinical and biological characterization, including dietary and physical activity questionnaires, anthropometric measurements, blood tests, liver imaging, and liver biopsy as part of routine care.
1 to 2 visits depending on timing of biopsy and assessments
Duration - Up to 10 years
Participants are observed over time for liver disease progression and other outcomes with data collection as part of routine care.
Visits as part of routine healthcare
Trial Site Locations
Total: 1 location
1
Batiment Archimed 151, route de Saint Antoine de Ginestière
Nice, France
Actively Recruiting
Research Team
R
Rodolphe Anty, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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