Comparison of patients with alcoholic liver disease and healthy controls
Comparison of ALD, NASH, and Healthy Control Patients
This study is collecting samples from people with alcoholic liver disease and healthy individuals to see how certain markers and genes might affect the disease and its treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT03224949 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect biological samples from individuals with varying stages of alcoholic liver disease (ALD) as well as healthy controls. The samples, including plasma, serum, and urine, will be utilized to investigate specific biomarkers and genetic factors that may influence disease severity and treatment responses. By establishing a biorepository, the study seeks to enhance the understanding of ALD and its progression, ultimately aiding in the development of targeted therapies. The research is part of the Clinical Core component of the Northern Ohio Alcohol Center.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with alcoholic liver disease at various stages, including steatosis, hepatitis, and cirrhosis.
Not a fit: Patients with liver disease not related to alcohol consumption or those without significant liver impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic strategies for patients with alcoholic liver disease.
How similar studies have performed: Other studies have shown promise in utilizing biological samples to understand liver diseases, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Srinivisan Dasarathy, MD — Staff
- Study coordinator: Annette Bellar, MSLA
- Email: bellara@ccf.org
- Phone: 216-636-5247
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.