Completed

NCT Number: NCT03307408

Hepatocellular Carcinoma in Patients With a Cirrhosis Due to an Alcoholic or a Non Alcoholic Fatty Liver Disease

Global prevalence of Non Alcoholic Fatty Liver Diseases (NAFLD) ranges from 22% to 28%.The spectrum of these hepatic abnormalities extends from isolated steatosis to steatohepatitis (Non Alcoholic Steato-Hepatitis, NASH) and steatofibrosis leading to cirrhosis and hepatocellular carcinoma. NAFLD is one of the main causes of cirrhosis and increases the risk of liver-related death and hepatocellular carcinoma (developed in patients with or without cirrhosis). Despite this major public health concern, apart from lifestyle changes, treatment of NAFLD is still elusive as there is lack of efficacious pharmacological treatment. Alcoholic liver diseases are also frequent in Western countries. Alcoholic liver diseases and NAFLD share common pathological lesions and molecular pathways. This is illustrated by the emerging role of abnormalities of the microbiota (dysbiosis) in these 2 diseases leading to the concept of " liver-gut axis ". Whereas the molecular mechanisms responsible for the progression from a "safety" state to NASH or to a severe alcoholic steato-hepatitis are still unclear, hepatic inflammation is a key factor involved in the progression of NAFLD and alcoholic liver disease.

The hypothesis is that cellular and molecular abnormalities and gut dysbiosis could be present in patients with simple steatosis or with steato-hepatitis and could be responsible for the occurrence of hepatocellular carcinoma particularly without cirrhosis.

The main objective is to compare cellular and inflammatory pathways in liver with and without hepatocellular carcinoma in patients with alcoholic or non-alcoholic fatty liver diseases.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nice

Nice, 06000, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Group 1

Inclusion criteria

Available social insurance
Signed consent for the study enrollment
Age ≥ 18 years

Exclusion criteria

Patients in the group with metabolic fatty liver with hepatocellular carcinoma
Alcohol consumption ≤ 30 g/d (or 210 g/week) in men and ≤ 20 g/d (or 140 g/week) in women.
Decision (less than 3 months) to perform a liver biopsy of a tumor suspect of HCC and of adjacent liver in routine practice.
No systemic HCC treatment in the previous 6 months

Group 2

Inclusion criteria

Available social insurance
Signed consent for the study enrollment
Age ≥ 18 years

Exclusion criteria

Patients in the group with metabolic fatty liver without hepatocellular carcinoma
Alcohol consumption ≤ 30 g/d (or 210 g/week) in men and ≤ 20 g/d (or 140 g/week) in women.
Decision (less than 3 months) to perform a liver biopsy in routine practice. Liver biopsy will be organized because of one or more liver abnormalities and/or fatty liver seen at liver ultrasound due to the current lack of validated non-invasive marker of inflammation, cellular death and fibrosis in these patients.

Group 3

Inclusion criteria

Available social insurance
Signed consent for the study enrollment
Age ≥ 18 years

Exclusion criteria

Patients with an alcoholic liver disease with hepatocellular carcinoma
Alcohol consumption > 30 g/d (or 210 g/week) in men and > 20 g/d (or 140 g/week) in women.
Decision (less than 3 months) to perform a liver biopsy of a tumor suspect of HCC and of adjacent liver in routine practice.
No systemic HCC treatment in the previous 6 months

Group 4

Inclusion criteria

Available social insurance
Signed consent for the study enrollment
Age ≥ 18 years

Exclusion criteria

Patients with an alcoholic liver disease without hepatocellular carcinoma
Alcohol consumption > 30 g/d (or 210 g/week) in men and > 20 g/d (or 140 g/week) in women.
Decision (less than 3 months) to perform a liver biopsy in routine practice. No systemic HCC treatment in the previous 6 months. Liver biopsy will be organized because of one or more liver abnormalities and/or fatty liver seen at liver ultrasound due to the current lack of validated non-invasive marker of inflammation, cellular death and fibrosis in these patients.

Treatment and study plan

Blood collection

Other

Standard routine practice clinico-biological data will be collected

Primary outcomes

Dosage of immunity cells in liver

Time frame: 8 weeks

The investigators determine the stage of liver by biochemical, genetic (and immunocytochemistry methods.
Dosage of the inflammatory cells in liver

Time frame: 8 weeks

The investigators determine the stage of liver by biochemical, genetic and immunocytochemistry methods.

Secondary outcomes

Dosage of the glucose

Time frame: 8 weeks

The investigators determine the genes implicated in oxidative stress, reticulum endoplasmic stress and autophagy .

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: CHALNA

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2022
First posted: Oct 11, 2017
Registry last updated: Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed