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
481 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
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
Official Title
CHronic Hepatopathies Associated With ALcohol Consumption aNd metAbolic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Affiliation to French social security
- Male or female aged 18 years or older
- Ability to understand study information and provide written informed consent
- For NAFLD group with HCC: alcohol consumption ≤ 30 g/day for men, ≤ 20 g/day for women; liver biopsy decision within 3 months; no systemic HCC treatment within 6 months
- For NAFLD group without HCC: alcohol consumption ≤ 30 g/day for men, ≤ 20 g/day for women; liver biopsy decision within 3 months motivated by liver function disturbance or ultrasound steatosis
- For alcohol-related liver disease group with HCC: alcohol consumption > 30 g/day for men, > 20 g/day for women or binge drinking; liver biopsy decision within 3 months; no systemic HCC treatment within 6 months
- For alcohol-related liver disease group without HCC: alcohol consumption > 30 g/day for men, > 20 g/day for women or binge drinking; liver biopsy decision within 3 months motivated by liver balance disturbance or ultrasound steatosis
You will not qualify if you...
- Positive HIV serology
- Detectable hepatitis C viral load
- Presence of hepatitis B surface antigen
- History of autoimmune hepatitis type 1 or 2, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, genetic haemochromatosis homozygous, or alpha1 anti-trypsin deficiency
- Long-term use of methotrexate, corticosteroids, anti-Tumor Necrosis Factor agents, cyclosporine, or tacrolimus
- History of solid organ or bone marrow transplantation
- Active cancer treatment except for non-melanoma skin cancer
- Under legal protection or unable to provide consent
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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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
CONTACT
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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