Comparison of ALD, NASH, and Healthy Control Patients

Conditions

• ALD - Alcoholic Liver Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Accepted

Interventions

• Blood draw — OTHER
  Patients will have a one time blood draw

Study Details

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.

Key Dates

Start date

Jun 19, 2017

Status verified

Nov 2025

Primary completion

Sep 30, 2027

Completion

Sep 30, 2028

Study Design

Enrollment

500 participants (estimated)

Arms

• Arm: Healthy controls
• Arm: Alcoholic hepatitis
• Arm: Alcoholic steatosis
• Arm: Alcoholic cirrhosis without HCC
• Arm: Nonalcoholic steatohepatitis (NASH)
• Arm: Alcoholic cirrhosis with HCC

Primary Outcome Measure

Biorepository [ Time Frame: This is a 5 year study ]

Central Contacts

• Annette Bellar, MSLA
  216-636-5247
  [email protected]
• Revathi Penumatsa, MD
  216 445-0688
  [email protected]

Locations (1)

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