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Scientists collect samples to unlock secrets of alcoholic liver disease

NCT ID NCT03224949

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study collects blood and urine samples from 500 people with alcoholic liver disease, heavy drinkers without liver disease, and healthy non-drinkers. The goal is to create a biorepository that researchers can use to study biomarkers and improve understanding of the disease. Participants provide samples once, with no treatment involved.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this biorepository could help researchers discover biomarkers to better diagnose and treat alcoholic liver disease.
What could go wrong
This is an observational study that does not test any treatment. It only collects samples for future research, so there is no direct benefit to participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2017

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients will be recruited from within Cleveland Clinic

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

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