Comparison of ALD, NASH, and Healthy Control Patients
1 other identifier
observational
500
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 19, 2017
CompletedFirst Submitted
Initial submission to the registry
July 19, 2017
CompletedFirst Posted
Study publicly available on registry
July 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2028
December 1, 2025
November 1, 2025
10.3 years
July 19, 2017
November 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Biorepository
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
Study Arms (6)
Healthy controls
Alcoholic hepatitis
Alcoholic steatosis
Alcoholic cirrhosis without HCC
Nonalcoholic steatohepatitis (NASH)
Alcoholic cirrhosis with HCC
Interventions
Patients will have a one time blood draw
Eligibility Criteria
Patients will be recruited from within Cleveland Clinic
You may qualify if:
- 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
- Steatosis plus hepatocellular damage (presence of Mallory bodies and hepatocellular ballooning)
- Polymorphonuclear infiltrate
- Fibrosis stage 1-2
- Alcoholic Hepatitis with Advanced Fibrosis
- Steatosis plus hepatocellular damage (presence of Mallory bodies and hepatocellular ballooning)
- Polymorphonuclear infiltrate
- Fibrosis stage 3-4.
- Alcoholic Cirrhosis
- 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
- 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.
You may not qualify if:
- 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
- Cancer
- Diabetes
- Hypertension
- CAD or stroke
- Past history of liver disease
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Related Publications (1)
Helsley RN, Miyata T, Kadam A, Varadharajan V, Sangwan N, Huang EC, Banerjee R, Brown AL, Fung KK, Massey WJ, Neumann C, Orabi D, Osborn LJ, Schugar RC, McMullen MR, Bellar A, Poulsen KL, Kim A, Pathak V, Mrdjen M, Anderson JT, Willard B, McClain CJ, Mitchell M, McCullough AJ, Radaeva S, Barton B, Szabo G, Dasarathy S, Garcia-Garcia JC, Rotroff DM, Allende DS, Wang Z, Hazen SL, Nagy LE, Brown JM. Gut microbial trimethylamine is elevated in alcohol-associated hepatitis and contributes to ethanol-induced liver injury in mice. Elife. 2022 Jan 27;11:e76554. doi: 10.7554/eLife.76554.
PMID: 35084335DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Srinivisan Dasarathy, MD
Staff
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Physician
Study Record Dates
First Submitted
July 19, 2017
First Posted
July 21, 2017
Study Start
June 19, 2017
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
September 30, 2028
Last Updated
December 1, 2025
Record last verified: 2025-11