Comparison of ALD, NASH, and Healthy Control Patients

Recruiting

• Conditions: ALD - Alcoholic Liver Disease
• Interventions: Other: Blood draw

• Registration Number: NCT03224949
• Lead Sponsor: The Cleveland Clinic

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-19
• Study First Submitted: 2017-07-19
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Alcoholic cirrhosis with HCC	Blood draw	-
Nonalcoholic steatohepatitis (NASH)	Blood draw	-
Healthy controls	Blood draw	-
Alcoholic cirrhosis without HCC	Blood draw	-
Alcoholic hepatitis	Blood draw	-
Alcoholic steatosis	Blood draw	-

Primary Outcome Measures

Name	Time	Method
Biorepository	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

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States