Can genes predict liver cancer? new study seeks answers
NCT ID NCT05623150
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is recruiting 710 adults with fatty liver disease or alcohol-related liver disease, with or without cirrhosis, to understand why some develop liver cancer. Researchers will analyze genetic markers, immune factors, and imaging data from routine liver biopsies and blood samples. The goal is to find early molecular clues that could one day help predict or prevent liver cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help identify people at high risk for liver cancer earlier, potentially leading to better monitoring or prevention strategies.
- What could go wrong
- This is an observational study, not a treatment trial. It may not directly lead to new therapies, and results may take years to translate into clinical practice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 710 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2022
- Expected to finish
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Mar 2032
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Criteria common to all patients: 1. Affiliation to French social security. 2. Male or female ≥ 18 years of age 3. 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: 1. 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. 2. Decision, less than 3 months old, of liver biopsy of the suspected HCC nodule and non-tumour liver tissue performed as a clinical routine. 3. No systemic treatment for HCC within 6 months prior to inclusion. * Patients in the NAFLD group without HCC: 1. 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. 2. 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: 1. 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 2. Decision within 3 months of liver biopsy of suspected HCC nodule and non-tumour liver tissue performed as part of clinical routine 3. No systemic treatment for HCC within 6 months prior to inclusion. * Patients in the alcohol-related liver disease group without HCC: 1. 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 2. 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. Exclusion Criteria: 1. Positive HIV serology 2. Patients with detectable hepatitis C viral load 3. Presence of Hbs antigen 4. History of autoimmune hepatitis type 1 or 2, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, genetic haemochromatosis homozygous, alpha1 anti-trypsin deficiency 5. Long-term use of methotrexate, corticosteroids, anti-Tumor Necrosis Factor cyclosporine, tacrolimus 6. History of solid organ transplantation or bone marrow transplantation 7. Cancerous disease in the process of being treated, except for skin cancer (excluding melanoma) 8. Patients under legal protection or unable to express their consent, 9. Pregnant or breastfeeding women
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Batiment Archimed 151, route de Saint Antoine de Ginestière
RECRUITINGNice, France
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