Understanding Alcohol-related Liver Disease in Europe

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on the progression of alcohol-related liver disease, including conditions such as fatty liver, fibrosis, and alcoholic hepatitis. It aims to utilize non-invasive diagnostic methods to track disease progression and identify patients at risk of developing cirrhosis. By studying asymptomatic heavy drinkers, the research seeks to establish risk cut-offs for cirrhosis development and improve screening strategies for patients with significant liver damage. The study will involve assessments like abdominal ultrasound and liver stiffness measurements to gather comprehensive data.

Why it matters

Who can join: the full rules

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

Where it's running

• Hop Claude Huriez Chu Lille
  Lille, France Recruiting

Study contacts

• Principal investigator: Philippe Mathurin, MD,PhD — University Hospital, Lille
• Study coordinator: Philippe Mathurin, MD,PhD
• Email: philippe.mathurin@chru-lille.fr
• Phone: 3 20 44 55 97

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Exploring the role of gut bacteria in alcoholic hepatitis

  This study is trying to see how gut bacteria affect liver damage in people with severe alcoholic hepatitis to find new ways to help them feel better.

  Recruiting Hospices Civils de Lyon · Lyon · NCT06307964

• Cohort study on the impact of gut microbiome in alcoholic liver disease

  This study is trying to see how the gut bacteria of heavy drinkers affects the development and worsening of alcoholic liver disease.

  Recruiting Assistance Publique - Hôpitaux de Paris · Clamart, Île-de-France Region · NCT05895890

• Evaluating liver disease screening for individuals with alcohol use disorder

  This study tests if screening for liver disease with a special measurement helps people in alcohol treatment stay sober or drink less over six months.

  Recruiting at 2 sites Zealand University Hospital · Køge and 1 other locations · NCT05855031

• HMB supplementation for patients with alcoholic liver disease and COVID-19

  This study is testing if HMB supplements can help people with alcoholic liver disease who also have COVID-19 feel better and recover more effectively.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT04858412

• Improving early diagnosis of liver disease using integrated diagnostics

  This study is trying to improve how quickly and accurately liver disease is diagnosed by combining different tests and information from around 750 patients who are at risk or have abnormal liver blood tests.

  Recruiting Manchester University NHS Foundation Trust · Manchester, Greater Manchester · NCT04666402

• Effects of a fermented powder on liver disease caused by alcohol

  This study is testing if a special fermented powder can help adults with liver disease caused by alcohol feel better over eight weeks.

  Recruiting Pusan National University Yangsan Hospital · Pusan, Ami-dong · NCT04320199

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.