NCT05623150

CHronic Hepatopathies Associated With ALcohol Consumption aNd metAbolic Syndrome

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 710 (estimated)
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2022-12-06
• Primary completion: 2032-01-01
• Completion: 2032-03-01
• First posted: 2022-11-21
• Last updated: 2026-04-16

Locations

1 site across 1 country: France