Biospecimen & Biomarker Development Core

摘要-生物标本和生物标志物开发核心 计划项目（PP）的目标是降低肝细胞癌（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）和预防策略（例如，与代谢相关的HCC的化学预防 （功能障碍）相关脂肪肝（MAFLD）。为了完成我们的目标，将需要反复收集， 运输、处理和储存数千份血液样本，这些血液样本可能与人口统计学和临床 数据这些样本来自德克萨斯州HCC联盟（THCCC）八个临床中心之一的参与者 前瞻性队列我们提出了3个项目，2个共享资源核心：生物标本和生物标志物 发展核心（BBDC）和数据和分析核心，以及行政核心。 BBDC的主要目标是1）生产高质量的DNA，血浆和血清用于研究 使用标准化收集和处理程序的项目，以及2）率先进行生物标志物测定 支持PP中项目的开发和验证。BBDC的目标是（1）接收， 处理和分类参加THCCC的患者的所有血液样本;（2）分配和分发 向研究者和项目提供适当的研究样本，并与生物样本优先级确定小组合作 （3）根据项目需要，开发和开展HCC生物标志物测定和分析;以及 (4)为未来的研究维护一个注释良好的样本生物库。 BBDC将作为中心位置，使用先前开发的标准全面支持这些功能 操作程序。BBDC将与数据和分析核心密切合作， 库存数据库，产生具有唯一样本条形码的标签，并产生具有特定 因此，可以提取所需的样品进行分析。BBDC还将提供最新和 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。样本处理和存储的集中化可确保一致、高质量的样本制备 这将有助于实现项目的目标并最大限度地降低成本。BBDC还将确保准确 记录保存和保护患者受保护的健康信息。重要的是，核心将提供以下方面的专门知识： 生物标志物检测开发和应用，监督样品制备，分析其他目标并联络 制度核心。因此，BBDC将为科学和技术发展提供不可或缺的服务， 成功的PP。

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.