Status:
RECRUITING
Study of Alcohol-related Liver Disease in Europe
Lead Sponsor:
University Hospital, Lille
Conditions:
Alcoholic Liver Disease
Eligibility:
All Genders
18-75 years
Brief Summary
Alcohol-induced liver injury is made up of fatty liver, fibrosis and alcoholic hepatitis (AH), elementary lesions that may occur separately, simultaneously or sequentially in a same patient. Among the...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 3 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2032
Estimated Enrollment :
7500 Patients enrolled
Trial Details
Trial ID
NCT04400604
Start Date
March 3 2021
End Date
March 1 2032
Last Update
March 17 2022
Active Locations (1)
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1
Hop Claude Huriez Chu Lille
Lille, France, 59037