# Core C: Clinical Core

> **NIH NIH P50** · CLEVELAND CLINIC LERNER COM-CWRU · 2020 · $168,148

## Abstract

ABSTRACT 
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 (tissue biopsy, plasma/serum, 
urine, DNA and peripheral blood mononuclear cells [PBMCs]) 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. The Clinical Core is comprised of three components, building on the established biorepositories and 
the diversity of outstanding clinical expertise at the Cleveland Clinic and Case Western Reserve University: 1) 
CoPath Database/Biospecimen Repository: The CoPath Database/Biospecimen Repository at the 
Cleveland Clinic allows investigators access to archived biopsy materials, with associated clinical data, initially 
used for diagnostic purposes, 2) CCF ALD biorepository: This biorepository included clinical samples 
(plasma, serum, PBMC, DNA 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. 3) CASH 
registry: The already established Case Alcoholic SteatoHepatitis (CASH) registry recruits inpatients admitted 
with the diagnosis of severe ASH and follows them at pre-determined intervals up to 365 days. The serial 
collection of clinical samples will allow for studies that require the ongoing management of an individual patient 
over time. The Clinical Core will be responsible for continuing to build the CCF-ALD biorepository and CASH 
registry biorepository via subject recruitment and communication, clinical specimen collection, subject 
characterization through clinical data acquisition and subject follow-up. The Clinical Core will interact 
intimately with the members of the NOAC to ensure distribution of clinical samples and data to Center 
investigators. In this capacity, the Clinical Core will function as a collective resource to the membership of the 
NOAC to support accomplishment of its major goal of facilitating the translation of novel findings in the 
basic mechanisms of ethanol action to clinical studies. This Core will also promote interaction between 
the different Research Components/Pilot Projects, ensuring that each of the valuable clinical samples obtained 
is utilized to its fullest possibilities.

## Key facts

- **NIH application ID:** 9900705
- **Project number:** 5P50AA024333-05
- **Recipient organization:** CLEVELAND CLINIC LERNER COM-CWRU
- **Principal Investigator:** ARTHUR Joseph MCCULLOUGH
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $168,148
- **Award type:** 5
- **Project period:** — → 2021-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9900705

## Citation

> US National Institutes of Health, RePORTER application 9900705, Core C: Clinical Core (5P50AA024333-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9900705. Licensed CC0.

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