Comparison of ALD, NASH, and Healthy Control Patients
- ALD - Alcoholic Liver Disease
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- The Cleveland Clinic
- Enrolment target
- 500
- Started
- 19 June 2017
- Main results due
- 30 September 2027
- Study sites
- 1
- Registry updated
- 25 September 2026
Can you take part?
- Ages 18 years to 75 years.
- Open to any sex.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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 sites(1)
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT03224949. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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