Study of Alcohol-related Liver Disease in Europe

Launched by UNIVERSITY HOSPITAL, LILLE · May 20, 2020

Keywords

ClinConnect Summary

This clinical trial is studying Alcoholic Liver Disease, which is caused by excessive drinking. It aims to better understand how liver damage progresses in people who drink heavily, particularly focusing on identifying those at risk of developing serious liver problems like cirrhosis or liver cancer. The researchers will use non-invasive tests to screen heavy drinkers for signs of liver damage, which could help in early detection and treatment.

To participate, individuals need to have been drinking heavily—more than 210 grams per week for men and 140 grams for women—over the past year. Participants must be willing to provide consent, undergo various assessments, and commit to a follow-up for at least five years. It’s important for potential participants to know that those with certain liver diseases or serious health conditions may not be eligible for the study. If you or someone you know fits the criteria and is interested in contributing to this important research, it could lead to better outcomes for people facing alcohol-related liver issues.

Gender

ALL

Eligibility criteria

• 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