An Observational Study Evaluating Patients With Chronic Liver Diseases Associated With Hepatic Steatosis

Study Overview
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Brief Summary
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Hepatic steatosis may cause inflammation and fibrosis within the liver potentially leading to end-stage liver disease cirrhosis, liver failure and death. The condition is associated with several other chronic liver diseases like autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, hereditary hemochromatosis and alpha-1-antitrypsin deficiency and may also develop secondary to other diseases like inflammatory bowel disease and chronic pancreatitis. Diagnosing chronic liver diseases can be challenging and treatment may be limited. In-depth phenotyping at a tissue level may generate insight into the underlying pathophysiology of diseases and furthermore identify common as well as specific diagnostic biomarkers and future treatment targets of the diseases. We therefore undertake a study that evaluates patients with chronic liver diseases associated with hepatic steatosis.

Official Title
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Fatty Liver Library (FALL): a Prospective Cohort Study Evaluating the Characteristics of Chronic Liver Diseases Associated With Hepatic Steatosis

Conditions
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Chronic Liver Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients/healthy control participants (age 18 or above) who can give their informed consent Suspected liver disease: non-alcoholic steatohepatitis alcoholic steatohepatitis autoimmune hepatitis primary biliary cholangitis primary sclerosing cholangitis inflammatory bowel disease polycystic ovary syndrome hereditary haemochromatosis chronic pancreatitis cystic fibrosis alpha-1 antitrypsin deficiency Exclusion Criteria: Patients with: malignant diseases viral hepatitis human immunodeficiency virus contraindications to liver biopsy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification and validation of a diagnostic classifier enabling discrimination of chronic liver diseases. | OMICS based analyses on plasma and liver tissue | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify any metabolic disturbances within chronic liver diseases | Collection of plasma during an oral glucose tolerance test measuring pancreatic and gut hormones | Plasma obtained at time point 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, steatosis, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, haemochromatosis, alfa-1-antitrypsin deficiency, chronic pancreatitis, chronic liver disease, inflammatory bowel disease, OMICS, Mass spectrometry