NCT03224949 · The Cleveland Clinic
Comparison of ALD, NASH, and Healthy Control Patients
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
- 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)
- Hypertension
- Hypercholesterolemia
- Coronary artery disease or stroke
- History of current or past liver disease of any etiology
- BMI \>27Kg/m2
Where
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 1, 2025 · Source of record for eligibility and locations