Comparison of ALD, NASH, and Healthy Control Patients

September 13, 2023 updated by: Srinivasan Dasarathy, The Cleveland Clinic
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Annette Bellar, MSLA
  • Phone Number: 216-636-5247
  • Email: bellara@ccf.org

Study Contact Backup

  • Name: Revathi Penumatsa, MD
  • Phone Number: 216 445-0688
  • Email: penumar@ccf.org

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Contact:
        • Principal Investigator:
          • Srinivasan Dasarathy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients will be recruited from within Cleveland Clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy controls
Other: Blood draw
Patients will have a one time blood draw
Alcoholic hepatitis
Other: Blood draw
Patients will have a one time blood draw
Alcoholic steatosis
Other: Blood draw
Patients will have a one time blood draw
Alcoholic cirrhosis without HCC
Other: Blood draw
Patients will have a one time blood draw
Nonalcoholic steatohepatitis (NASH)
Other: Blood draw
Patients will have a one time blood draw
Alcoholic cirrhosis with HCC
Other: Blood draw
Patients will have a one time blood draw

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
This is a 5 year study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Srinivisan Dasarathy, MD, Staff

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2017

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

July 19, 2017

First Submitted That Met QC Criteria

July 19, 2017

First Posted (Actual)

July 21, 2017

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-718

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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