Biospecimen & Biomarker Development Core

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ABSTRACT—Biospecimen and Biomarker Development Core The goal of the Program Project (PP) is to reduce the burden of hepatocellular carcinoma (HCC)-related mortality through better understanding of contemporary risk factors (e.g., phenotypic, biochemical and genetic markers of metabolic dysfunction) and preventive strategies (e.g., chemoprevention) of HCC related to metabolic (dysfunction) associated fatty liver disease (MAFLD). To accomplish our goal, will need repeated collection, shipping, processing and storage of thousands of blood samples that can be linked to demographic and clinical data. These samples come from participants at one of eight clinical sites of the Texas HCC Consortium (THCCC) prospective cohort. We propose 3 Projects, 2 shared resource Cores: Biospecimen and Biomarker Development Core (BBDC) and Data and Analysis Core, and the Administrative Core. The primary objectives of the BBDC are 1) to produce high-quality DNA, plasma, and serum for research projects using standardized collection and processing procedures and 2) to spearhead biomarker assay development and validation that supports the projects in the PP. The aims of the BBDC are to (1) receive, process, and catalog all blood samples from patients participating in the THCCC; (2) Allocate and distribute appropriate research samples to investigators and projects, and work with the biospecimen prioritization group to prioritize samples; (3) Develop and conduct HCC biomarker assays and analyses as needed for Projects; and (4) Maintain a biobank of well-annotated samples for future research. The BBDC will serve as the central location to fully support these functions using previously developed standard operating procedures. The BBDC will work closely with the Data and Analysis Core to maintain the sample inventory database, produce labels with unique sample barcodes, and produce lists of patients with specific characteristics, so the samples needed can be pulled for analysis. The BBDC will also provide up-to-date and accurate data on sample availability and ensure that the Projects receive optimal samples for the proposed analyses. Centralizing specimen processing and storage ensures consistent, high-quality sample preparation that will help achieve the goals of the Projects and minimize costs. The BBDC will also ensure accurate recordkeeping and guard patient protected health information. Importantly, the Core will provide expertise in biomarker assay development and application, oversee sample preparation, profile additional targets and liaise with institutional cores. Thus, the BBDC will provide indispensable services critical for the scientific and operational success of the PP.