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Recruiting NCT03224949

Comparison of ALD, NASH, and Healthy Control Patients

— Observational ALD - Alcoholic Liver Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood draw.
Who it may be relevant to
Registry conditions: ALD - Alcoholic Liver Disease. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Blood draw
    Patients will have a one time blood draw

Primary outcome measures

  • Biorepository [Time frame: This is a 5 year study]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Cleveland Clinic Foundation — Cleveland

Publications

  • 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. PMID 35084335

Identifiers

NCT: NCT03224949 · 17-718

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗