7,500 heavy drinkers to be tracked in landmark liver study
NCT ID NCT04400604
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows 7,500 heavy drinkers over time to learn how alcoholic liver disease develops and worsens. Researchers will use non-invasive tests like ultrasound and blood markers to identify who is at risk for cirrhosis and liver cancer. The goal is to improve screening and early detection, not to test a new treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 7,500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2021
- Expected to finish
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Mar 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This study will be conducted in adults patients with active alcohol excessive consumption defined as \> 210 g per week for men and\> 140 g per week for women during the previous year. Patients with high risk of alcoholic-related liver disease.
- Ages
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18 to 75 years
- 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: * Active alcohol excessive consumption defined as \> 210 g per week for men and\> 140 g per week for women during the previous year. * Patients with high risk of alcoholic-related liver disease can be included only if the following assessment were available: Abdominal Ultrasound / Ultrasound elastography pulse (FibroScan®) / FibroTest®, AshTest® and LCR1-LCR2® (cost will be supported by Biopredictive) / Non-patented methods: Forns Index; Fib-4, Hepascore®/ Absolute values should be provided for all these methods. For patient in whom liver stiffness measurements were uninterpretable (unavailable results) only those with FibroTest® and LCR1 and LCR2 measurements can be included. Results of FibroScan® were considered unavailable based on following criteria: When no value was obtained after at least 10 shots (valid shot=0) OR If SR (Success Rate), the ratio of valid shots to the total number of shots at least 60% OR IQR (InterQuartil Range reflecting variability of measurements) less than 30% of the median LSM (Liver Stiffness Measure) value (IQR≤LSM≤30%). * Patients must provide written informed consent and agree to have blood stored for the study and tissue stored for those in whom physicians performed liver biopsy according their clinical practice. * Patients should agree to participate for at least 5-year follow-up. * Patients with social insurance Exclusion Criteria: For all study groups, the following exclusion criteria will be applied: * Evidence of other forms of known chronic liver disease including:Positive test result at baseline for hepatitis B surface antigen or positive serology of hepatitis C virus infection (regardless PCR results)/ Autoimmune liver disease / Known or suspected HCC * Any previous episode of decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding before current hospitalization and/or inclusion in the study * Known positivity for human immunodeficiency virus infection. * Terminal extrahepatic illness defined as: All conditions evolved into a clinical stage to limit the patient's functional status (e.g.: heart failure, renal failure, neurological or respiratory diseases, or any other disabling diseases etc. …). * Other medical conditions that may diminish life expectancy to \<2 years. * Known extra-hepatic cancers with the exception of basal cell skin cancer. * Any other condition that, in the opinion of the Investigator, would impede completion of the study (eg: Homeless, non-compliant patients…). * Mental instability or incompetence, such that the validity of informed consent is uncertain. * Lack of informed consent or refusal to participate for follow up evaluation. * A condition in which repeated blood draws pose more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access. * Pregnant or lactating women
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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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Hop Claude Huriez Chu Lille
RECRUITINGLille, 59037, France
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Other studies related to the condition(s) this trial covers.
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