Comparison of ALD, NASH, and Healthy Control Patients

Study Overview
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Brief Summary
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The availability of biological samples from individuals with alcoholic liver disease (ALD), as well as samples from appropriate heavy drinking, yet healthy controls and non-drinking healthy controls, is an essential first step in the translation of basic research advances to the clinic. The purpose of the Clinical Core component of the P50 Northern Ohio Alcohol Center (NOAC) is to provide biological samples (plasma/serum, buffy coats, and urine) from patients with different stages of alcoholic liver disease, as well as healthy control subjects, to members of the NOAC. These samples can then be used to test specific hypotheses related to the presence of specific biomarkers in the serum, functional immune activity in PBMCs and/or genetic polymorphisms that may predict severity of disease, short- and long-term morbidity and mortality and/or responsivity to specific therapeutic interventions commonly used in clinical practice. This study is building on the established biorepositories and the diversity of outstanding clinical expertise at the Cleveland Clinic. This biorepository included clinical samples (plasma, serum, buffy coats, and urine) from patients with different stages of ALD and subjects who are heavy drinkers without ALD, recruited from the Cleveland Clinic alcohol use disorder treatment clinic. This study will be responsible for collecting more data to help build the CCF-ALD biorepository via subject recruitment and communication and specimen collection.

Official Title
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Comparison of ALD, NASH, and Healthy Control Patients

Conditions
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ALD - Alcoholic Liver Disease

Intervention / Treatment
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* Other: Blood draw


Participation Criteria
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Eligibility Criteria
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Alcoholic Steatosis Patients Inclusion Fat accumulation (Steatosis) without signs of fibrosis/ inflammation in patients with alcohol abuse (alcohol intake >60 g/day in men and >40 g/day in women) Abnormal liver serum tests indicative of liver disease (elevated AST>ALT, y-glutamyl transpeptidase and bilirubin) . Alcoholic Hepatitis with Mild Fibrosis Inclusion Steatosis plus hepatocellular damage (presence of Mallory bodies and hepatocellular ballooning) Polymorphonuclear infiltrate Fibrosis stage 1-2 Alcoholic Hepatitis with Advanced Fibrosis Inclusion Steatosis plus hepatocellular damage (presence of Mallory bodies and hepatocellular ballooning) Polymorphonuclear infiltrate Fibrosis stage 3-4. Alcoholic Cirrhosis Inclusion Fibrosis stage 4 Presence of complications of cirrhosis such as esophageal varices with our without a previous episode of bleeding, splenomegaly, ascites, hepatic corroborate the diagnosis of cirrhosis. Alcoholic Cirrhosis with HCC Inclusion -Diagnostic criteria of cirrhosis and established HCC. The diagnosis of HCC will be established based on histological confirmation or contrast-enhanced radiographic imaging according to the AASLD recommendations. Exclusion BMI>35 HBV Hemochromatosis Wilson's disease Autoimmune hepatitis Drug-inducted liver disease Hepatitis C Antitrypsin deficiency Patients who do not sign informed consent. Non-alcoholic steatohepatitis Inclusion -Biopsy proven NASH and chronic liver disease due to HCV patients. Exclusion Cancer Diabetes Hypertension CAD or stroke Past history of liver disease Hepatitis C Antitrypsin deficiency Alcohol consumption of less than 7 drinks per week for women and less than 14 drinks per week for men BMI >35. Healthy controls Inclusion -AUDIT-C score less than 4 in men and less than 3 in women. Exclusion Cancer (except of non-melanoma skin cancer) Diabetes Hypertension Hypercholesterolemia Coronary artery disease or stroke History of current or past liver disease of any etiology BMI >27Kg/m2

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy controls<br> | Other: Blood draw<br>* Patients will have a one time blood draw<br>|
| Alcoholic hepatitis<br> | Other: Blood draw<br>* Patients will have a one time blood draw<br>|
| Alcoholic steatosis<br> | Other: Blood draw<br>* Patients will have a one time blood draw<br>|
| Alcoholic cirrhosis without HCC<br> | Other: Blood draw<br>* Patients will have a one time blood draw<br>|
| Nonalcoholic steatohepatitis (NASH)<br> | Other: Blood draw<br>* Patients will have a one time blood draw<br>|
| Alcoholic cirrhosis with HCC<br> | Other: Blood draw<br>* Patients will have a one time blood draw<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biorepository | The goal of this study is to create a biorepository of samples from patients with different types of liver disease compared to each other and healthy controls | This is a 5 year study |