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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy controls |
| ||
| Alcoholic hepatitis |
| ||
| Alcoholic steatosis |
| ||
| Alcoholic cirrhosis without HCC |
| ||
| Nonalcoholic steatohepatitis (NASH) |
| ||
| Alcoholic cirrhosis with HCC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draw | Other | Patients will have a one time blood draw |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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
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Patients will be recruited from within Cleveland Clinic
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annette Bellar, MSLA | Contact | 216-636-5247 | bellara@ccf.org | |
| Revathi Penumatsa, MD | Contact | 216 445-0688 | penumar@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Srinivisan Dasarathy, MD | Staff | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35084335 | Derived | 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. |
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| ID | Term |
|---|---|
| D008108 | Liver Diseases, Alcoholic |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |