Biospecimen & Biomarker Development Core

摘要-生物样品与生物标志物开发核心 该计划项目(PP)的目标是减轻肝细胞癌(HCC)相关死亡率的负担 通过更好地了解当代风险因素(例如，表型、生化和遗传标记) 代谢功能障碍)与代谢相关的肝细胞癌的预防策略(如化学预防) (功能障碍)相关性脂肪肝(MAFLD)。为了实现我们的目标，将需要反复收集， 运输、处理和存储数以千计的血液样本，这些样本可能与人口统计学和临床有关 数据。这些样本来自德克萨斯肝细胞癌联盟(THCCC)八个临床站点之一的参与者 未来的队列。我们提出了3个项目，2个共享资源核：Biosecimen和Biomarker 开发核心(BBDC)和数据和分析核心，以及管理核心。 BBDC的主要目标是：1)生产用于研究的高质量DNA、血浆和血清 使用标准化收集和处理程序的项目和2)带头进行生物标记物分析 支持PP中的项目的开发和验证。BBDC的目标是(1)接收、 对参与THCCC的所有患者的血液样本进行处理和编目；(2)分配和分发 为研究人员和项目提供适当的研究样本，并与生物有机磷优先处理小组合作 确定样本的优先次序；(3)根据项目需要，开发和进行肝细胞癌生物标志物分析和分析；以及 (4)保存注解良好的样品生物库，以备将来研究之用。 BBDC将作为中心位置，使用以前开发的标准完全支持这些功能 操作程序。BBDC将与数据和分析核心密切合作，以维护样本 库存数据库，生成带有唯一样本条形码的标签，并生成特定患者的列表 因此，可以提取所需的样本进行分析。BBDC还将提供最新的和 关于样品可用性的准确数据，并确保项目收到建议的最佳样品 分析。集中样品处理和存储可确保一致、高质量的样品制备 这将有助于实现项目的目标，并将成本降至最低。BBDC还将确保准确 记录和保护患者保护的健康信息。重要的是，核心将在以下方面提供专业知识 生物标记物分析的开发和应用，监督样品的制备，分析其他目标和联络 以机构为核心。因此，BBDC将提供不可或缺的服务，对科学和 PP的运营成功。

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.