Actively Recruiting

Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT03224949

Comparison of ALD, NASH, and Healthy Control Patients

Led by The Cleveland Clinic · Updated on 2025-12-01

500

Participants Needed

1

Research Sites

588 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Comparison of ALD, NASH, and Healthy Control Patients

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 75 years
  • Fat accumulation (steatosis) without fibrosis or inflammation in patients with alcohol abuse (men >60 g/day, women >40 g/day)
  • Abnormal liver serum tests indicating liver disease (elevated AST>ALT, gamma-glutamyl transpeptidase, bilirubin)
  • Steatosis plus hepatocellular damage (Mallory bodies, ballooning), polymorphonuclear infiltrate, fibrosis stage 1-2 (alcoholic hepatitis with mild fibrosis)
  • Steatosis plus hepatocellular damage, polymorphonuclear infiltrate, fibrosis stage 3-4 (alcoholic hepatitis with advanced fibrosis)
  • Fibrosis stage 4 with complications of cirrhosis such as esophageal varices, splenomegaly, ascites, or hepatic corroboration
  • Diagnostic criteria of cirrhosis and established hepatocellular carcinoma confirmed by histology or imaging
  • Biopsy-proven NASH and chronic liver disease due to hepatitis C virus
  • Healthy controls with AUDIT-C score less than 4 in men and less than 3 in women
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) greater than 35
  • Hepatitis B virus infection
  • Hemochromatosis
  • Wilson's disease
  • Autoimmune hepatitis
  • Drug-induced liver disease
  • Hepatitis C virus infection (except biopsy-proven NASH group)
  • Antitrypsin deficiency
  • Patients who do not sign informed consent
  • Cancer (except non-melanoma skin cancer in healthy controls)
  • Diabetes
  • Hypertension
  • Hypercholesterolemia
  • Coronary artery disease or stroke
  • Past history of liver disease (except in study groups)
  • Alcohol consumption less than 7 drinks per week for women and less than 14 drinks per week for men (for NASH group)
  • Body mass index (BMI) greater than 27 kg/m2 for healthy controls

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

A

Annette Bellar, MSLA

CONTACT

R

Revathi Penumatsa, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

6

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