Comparison of ALD, NASH, and Healthy Control Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 21 - 75 |
| Updated: | 10/10/2018 |
| Start Date: | June 19, 2017 |
| End Date: | July 31, 2022 |
| Contact: | Annette Bellar, MSLA |
| Email: | bellara@ccf.org |
| Phone: | 216-636-5247 |
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.
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.
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
We found this trial at
1
site
2049 E 100th St
Cleveland, Ohio 44106
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Srinivasan Dasarathy, MD
Phone: 216-636-5247
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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