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.
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