Comparison of ALD, NASH, and Healthy Control Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorThe Cleveland Clinic

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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) .

Steatosis plus hepatocellular damage (presence of Mallory bodies and hepatocellular ballooning)

Polymorphonuclear infiltrate

Disqualifiers

None

Trial population

Patients will be recruited from within Cleveland Clinic

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Blood draw

    Other intervention

    Patients will have a one time blood draw

Treatment groups

500 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Healthy controls1 intervention
Group B: Alcoholic hepatitis1 intervention
Group C: Alcoholic steatosis1 intervention
Group D: Alcoholic cirrhosis without HCC1 intervention
Group E: Nonalcoholic steatohepatitis (NASH)1 intervention
Group F: Alcoholic cirrhosis with HCC1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
This is a 5 year study

Secondary outcomes

Other outcomes

Sponsors and contacts

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