CHronic Hepatopathies Associated With ALcohol Consumption aNd metAbolic Syndrome (NCT05623150) | Clinical Trial Compass
RecruitingNot Applicable
CHronic Hepatopathies Associated With ALcohol Consumption aNd metAbolic Syndrome
France710 participantsStarted 2022-12-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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).
✓. 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.
✓. 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.
Exclusion criteria
✕. Positive HIV serology
✕. Patients with detectable hepatitis C viral load