ALD - Alcoholic Liver DiseaseNCT03224949
Comparison of ALD, NASH, and Healthy Control Patients
An observational study of ALD - Alcoholic Liver Disease, run by The Cleveland Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- ALD - Alcoholic Liver Disease
- What is being tested?
- Blood draw
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2017to 30 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be recruited from within Cleveland Clinic
Who may be able to join
- 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
- Steatosis plus hepatocellular damage (presence of Mallory bodies and hepatocellular ballooning)
- Polymorphonuclear infiltrate
- Fibrosis stage 1-2
Show all 16Show fewer
- Alcoholic Hepatitis with Advanced Fibrosis
- Steatosis plus hepatocellular damage (presence of Mallory bodies and hepatocellular ballooning)
- Polymorphonuclear infiltrate
- Fibrosis stage 3-4.
- Alcoholic Cirrhosis
- 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
- -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.
- -AUDIT-C score less than 4 in men and less than 3 in women.
Who cannot join
- BMI>35
- HBV
- Hemochromatosis
- Wilson's disease
- Autoimmune hepatitis
- Drug-inducted liver disease
Show all 28Show fewer
- 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.
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Annette Bellar, BS, 216-636-5247, bellara@ccf.org
Megan Villareal, BS, 216-636-5247, villarm@ccf.org
About this study
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.
- Conditions
- ALD - Alcoholic Liver Disease
- Being tested
- Blood draw
- Medical subject headings
- Liver Diseases, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawOther
Patients will have a one time blood draw
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Not described Receives: Other: Blood draw | |
| Alcoholic hepatitis | Not described Receives: Other: Blood draw | |
| Alcoholic steatosis | Not described Receives: Other: Blood draw | |
| Alcoholic cirrhosis without HCC | Not described Receives: Other: Blood draw | |
| Nonalcoholic steatohepatitis (NASH) | Not described Receives: Other: Blood draw | |
| Alcoholic cirrhosis with HCC | Not described Receives: Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: This is a 5 year study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start19 Jun 2017
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ALD - Alcoholic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srinivasan Dasarathy, The Cleveland Clinic
- Investigators
- Srinivisan Dasarathy, MD, Principal investigator, Staff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224949
- Sponsor's protocol ID
- 17-718
- Status last verified
- Sep 2026
- First submitted
- 19 Jul 2017
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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. 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.
PubMed 35084335
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of ALD, NASH, and Healthy Control Patients
- ClinicalTrials.gov ID
- NCT03224949
- Acronym / sponsor ID
- 17-718
- Conditions
- ALD - Alcoholic Liver Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Other: Blood draw |
| Alcoholic hepatitis | – | Other: Blood draw |
| Alcoholic steatosis | – | Other: Blood draw |
| Alcoholic cirrhosis without HCC | – | Other: Blood draw |
| Nonalcoholic steatohepatitis (NASH) | – | Other: Blood draw |
| Alcoholic cirrhosis with HCC | – | Other: Blood draw |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from within Cleveland Clinic
Key inclusion criteria (16 listed)
- 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
- Steatosis plus hepatocellular damage (presence of Mallory bodies and hepatocellular ballooning)
- Polymorphonuclear infiltrate
Key exclusion criteria (28 listed)
- BMI>35
- HBV
- Hemochromatosis
- Wilson's disease
- Autoimmune hepatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawPatients will have a one time blood draw | Other | Alcoholic cirrhosis with HCC, Alcoholic cirrhosis without HCC, Alcoholic hepatitis, Alcoholic steatosis, Healthy controls, Nonalcoholic steatohepatitis (NASH) |
Primary outcome
Biorepository
Time frame: This is a 5 year study
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Derived from this study: PubMed 35084335Helsley 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Srinivisan Dasarathy, MD principal investigator
Staff
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALD - Alcoholic Liver Disease, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annette Bellar, MSLA (216-636-5247, bellara@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biorepository (time frame: This is a 5 year study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03224949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.