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NCT Number: NCT03224949

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.

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Key information

Conditions

ALD - Alcoholic Liver Disease Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Digestive System Diseases Liver Diseases Liver Diseases, Alcoholic Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Draw

Other

Patients will have a one time blood draw

Primary outcomes

  1. Biorepository

    Time frame: This is a 5 year study

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Annette Bellar, MSLA

CONTACT

[email protected]

216-636-5247

Revathi Penumatsa, MD

CONTACT

[email protected]

216 445-0688

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2017
Primary completion
2027
Study completion
2028
First posted
Jul 21, 2017
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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