Comparison of patients with alcoholic liver disease and healthy controls

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect biological samples from individuals with varying stages of alcoholic liver disease (ALD) as well as healthy controls. The samples, including plasma, serum, and urine, will be utilized to investigate specific biomarkers and genetic factors that may influence disease severity and treatment responses. By establishing a biorepository, the study seeks to enhance the understanding of ALD and its progression, ultimately aiding in the development of targeted therapies. The research is part of the Clinical Core component of the Northern Ohio Alcohol Center.

Why it matters

Who can join: the full rules

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

Where it's running

• Cleveland Clinic Foundation
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Srinivisan Dasarathy, MD — Staff
• Study coordinator: Annette Bellar, MSLA
• Email: bellara@ccf.org
• Phone: 216-636-5247

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.