An observational study in ALD - Alcoholic Liver Disease, sponsored by The Cleveland Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by The Cleveland Clinic · Observational
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.
Patients will be recruited from within Cleveland Clinic
Alcoholic Steatosis Patients
Inclusion
Alcoholic Hepatitis with Mild Fibrosis
Inclusion
Alcoholic Hepatitis with Advanced Fibrosis
Inclusion
Alcoholic Cirrhosis
Inclusion
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
Non-alcoholic steatohepatitis
Inclusion -Biopsy proven NASH and chronic liver disease due to HCV patients.
Exclusion
Healthy controls
Inclusion
-AUDIT-C score less than 4 in men and less than 3 in women.
Exclusion
Other: Blood draw
Other: Blood draw
Other: Blood draw
Other: Blood draw
Other: Blood draw
Other: Blood draw
Patients will have a one time blood draw
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
Time frame: This is a 5 year study
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Cleveland Clinic