Non-Alcoholic Fatty Liver DiseaseCHALNA2NCT05623150
CHronic Hepatopathies Associated With ALcohol Consumption aNd metAbolic Syndrome
An observational study of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis, Alcohol-related Liver Disease
- What is being tested?
- Liver biopsy
- How many people
- 710 participants
- Where
- 1 siteFrance
- Study dates
- 6 Dec 2022to Mar 2032
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- Criteria common to all patients:
- 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).
- Patients in the NAFLD group with HCC:
- 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.
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- 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.
- Patients in the NAFLD group without HCC:
- 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.
- Patients in the alcohol-related liver disease group with HCC:
- 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) or binge drinking
- Decision within 3 months of liver biopsy of suspected HCC nodule and non-tumour liver tissue performed as part of clinical routine
- No systemic treatment for HCC within 6 months prior to inclusion.
- Patients in the alcohol-related liver disease group without HCC:
- 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) or binge drinking
- Decision of less than 3 months for a liver biopsy to be performed as a clinical routine. Biopsy will be motivated by liver balance 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.
Who cannot join
- 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
- Long-term use of methotrexate, corticosteroids, anti-Tumor Necrosis Factor cyclosporine, tacrolimus
- History of solid organ transplantation or bone marrow transplantation
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- Cancerous disease in the process of being treated, except for skin cancer (excluding melanoma)
- Patients under legal protection or unable to express their consent,
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Batiment Archimed 151, route de Saint Antoine de Ginestière
Nice
About this study
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.
Read the 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
- Being tested
- Liver biopsy
- Keywords
- Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis, Alcohol-related Liver Disease, Cirrhosis, Liver, Hepatocellular Carcinoma
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver biopsyDiagnostic test
Liver biopsy planned as part of routine care. Clinical-biological characterisation with bio collections.
| Study group | Role | What they receive |
|---|---|---|
| Descriptive study | 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. Receives: Diagnostic Test: Liver biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2022-2032
Secondary outcomes (6)
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.
Measured: 2022-2032
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.
Measured: 2022-2032
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.
Measured: 2022-2032
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.
Measured: 2022-2032
6th outcome measure CHALNA2
6th endpoint will include variations in specific markers or markers derived from analysis via platforms (OMICS), in patients with and without hepatocellular carcinoma with different levels of severity of liver damage.
Measured: 2022-2032
7th outcome measure CHALNA2
7th endpoint will include variations in radiomics (radiomics is a method that extracts a large number of features from medical images using data-characterisation algorithms), in patients with and without hepatocellular carcinoma with different levels of severity of liver damage.
Measured: 2022-2032
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start6 Dec 2022
- Primary completionJan 2032 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 710 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Centre Hospitalier Universitaire de Nice
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623150
- Sponsor's protocol ID
- C20-12
- Acronym
- CHALNA2
- Status last verified
- Apr 2026
- First submitted
- 27 Dec 2021
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No