Comparison of ALD, NASH, and Healthy Control Patients
Comparison of ALD, NASH, and Healthy Control Patients
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.
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