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CompletedNCT03307408CHALNAUpdated Jun 16, 2026

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

An observational study in Hepatocellular Carcinoma, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Centre Hospitalier Universitaire de Nice · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
180
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hepatocellular Carcinoma
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with alcoholic or non-alcoholic fatty liver diseases.

Eligibility criteria

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
180 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • Otherblood collection

    Standard routine practice clinico-biological data will be collected

05

What researchers measure

Primary outcomes

  1. Dosage of immunity cells in liver

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

    Time frame: 8 weeks

  2. Dosage of the inflammatory cells in liver

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

    Time frame: 8 weeks

Secondary outcomes

  1. Dosage of the glucose

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

    Time frame: 8 weeks

06

Study locations

1 site
  • CHU de Nice
    Nice, 06000, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03307408
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Oct 11, 2017
Start date
Feb 28, 2017
Primary completion
Feb 1, 2020
Completion
Sep 1, 2022
Last update
Jun 16, 2026

Study contacts

Rodolphe ANTY, MD
principal investigator · Centre Hospitalier Universitaire de Nice

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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