CHronic Hepatopathies Associated With ALcohol Consumption aNd metAbolic Syndrome

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut National de la Santé Et de la Recherche Médicale, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Positive HIV serology

Patients with detectable hepatitis C viral load

Presence of Hbs antigen

History of autoimmune hepatitis type 1 or 2, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, genetic haemochromatosis homozygous, alpha1 anti-trypsin deficiency

Trial population

The patients included in this observational study are patients with hepatic steatosis either related to NAFLD or to alcohol-related liver disease. Patients included in the study may have hepatocellular carcinoma. Thus, 4 groups of patients can be recruited: patients with NAFLD without hepatocellular carcinoma, patients with NAFLD with hepatocellular carcinoma, patients with alcohol-related liver disease without hepatocellular carcinoma, patients with alcohol-related liver disease with hepatocellular carcinoma.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Liver biopsy

    Diagnostic test

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

Treatment groups

710 Participants
are divided into 1 treatment group
Group A: Descriptive study1 intervention

Trial outcomes

Primary outcomes

1

Primary outcome measure CHALNA2

The primary endpoint will be the study of variations in metabolic gene markers (i.e. mRNA of genes implicated in inflammation or metabolism assessed in qPCR, using a housekeeping gene such as glyceraldehyde-3-phosphate dehydrogenase (GAPDH)), in patients with and without hepatocellular carcinoma with different levels of severity of liver damage.

Time frame
2022-2032

Secondary outcomes

1

Secondary outcome measure CHALNA2

Secondary endpoint will include variations in other gene markers (e.g. genes implicated in the regeneration, cell deaths and tumor, assessed in qPCR, using a housekeeping gene such as glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) in patients with and without hepatocellular carcinoma with different levels of severity of liver damage.

Time frame
2022-2032
2

3th outcome measure CHALNA2

3th endpoint will include variations in genetic markers (Single Nucleotide Polymorphisms (SNPs)), in patients with and without hepatocellular carcinoma with different levels of severity of liver damage. The frequency of SNPs will be compared to that found in the UK biobank cohort.

Time frame
2022-2032
3

4th outcome measure CHALNA2

4th endpoint will include variations in epigenetic markers (histone methylation, micro RNA), in patients with and without hepatocellular carcinoma with different levels of severity of liver damage.

Time frame
2022-2032
4

5th outcome measure CHALNA2

5th endpoint will include variations in tissue proteins (including tumor and non tumor tissue), in patients with and without hepatocellular carcinoma with different levels of severity of liver damage. Western blots will be quantified and compared in an automated way.

Time frame
2022-2032

Other outcomes

Sponsors and contacts

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