# Clinical Core

> **NIH NIH P50** · CLEVELAND CLINIC LERNER COM-CWRU · 2021 · $186,569

## 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 (plasma/serum, urine, feces, 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 circulating biomarkers, 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 two components, building on the established biorepositories and the diversity of outstanding clinical
expertise at the Cleveland Clinic and MetroHealth Medical Center: 1) NOAC biorepository: This biorepository
included clinical samples (plasma, serum, PBMC, DNA, feces and urine), as well as clinical and demographic
data from liver disease patients and healthy controls and 2) 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. A Pathologist specializing in liver
disease provides expertise in the analysis and interpretation of histological and immunohistochemical analysis
of biopsy samples. The NOAC now has a robust biorepository including clinical and demographic data from
patients with alcoholic hepatitis (n=93) and alcoholic cirrhosis (n=19), as well as NASH patients (n=26). Both
lean and obese healthy controls (n=45) have been recruited. In the renewal application, the Clinical Core will
be responsible for continuing to build the NOAC biorepository via subject recruitment and communication, clinical
specimen collection, subject characterization through clinical data acquisition and subject follow-up. We are
currently recruiting from both CCF and MetroHealth Medical Center, with MetroHealth providing better access to
patients from minority populations, as well as heavy drinkers without disease. 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 promote interaction between Research
Components/Pilo...

## Key facts

- **NIH application ID:** 10056028
- **Project number:** 2P50AA024333-06
- **Recipient organization:** CLEVELAND CLINIC LERNER COM-CWRU
- **Principal Investigator:** JAIVIDHYA DASARATHY
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $186,569
- **Award type:** 2
- **Project period:** 2016-05-01 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10056028

## Citation

> US National Institutes of Health, RePORTER application 10056028, Clinical Core (2P50AA024333-06). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10056028. Licensed CC0.

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