Core 1: Specimen and Data Core

摘要：样本和数据核心 拟议的样本和数据核心将在这一高度集成的计划中发挥几个核心作用 项目：1)同意将所有默克尔细胞癌(MCC)患者纳入我们的纵向研究 研究；2)它将获取、处理和存储所有患者的血液和肿瘤组织，并将它们分发给相关的 项目和免疫表型核心；以及3)它将随着时间的推移获得患者的临床数据，并存储 研究派生的患者结果，用相应的疾病状态对样本进行注释。建议数 CORE将扩展我们现有的MCC标本库，其中包括来自 1,400名患者(截至2018年5月)和我们注释这些样本和患者的关系数据库 使用包括临床治疗、疾病状态和反应在内的大约200个数据字段的人口统计学 数据，以及研究实验室的结果。 样本和数据核心拟议的基本新角色将是获取肿瘤样本(包括 为研究目的而获得的活组织检查，而不仅仅是临床需要的活组织检查 PD-1检查点阻断治疗前后。获得这样的组织是复杂和费力的，但也 对于了解对这些重要的新免疫疗法的应答和无应答的基础是必不可少的。 关系数据库的扩展将涉及添加30多个字段来捕获新的 与免疫治疗相关的结果和实验数据，这将对这些项目以及 免疫表型核心和生物统计学与生物信息学核心。样本和数据核心还将跟踪 MCPyV癌蛋白抗体滴度有助于a)检测早期疾病复发，b)了解如何 在接受PD-1检查点阻断治疗的患者中使用这项最近开发的测试，以及c)协助 项目3了解为什么这些抗体在肿瘤切除时迅速下降的生物学基础。 最后，样本和数据核心将通过与 通过已被证明极具成效的协作研究，扩大MCC和科学界 过去，有43份出版物(截至2018年5月)利用了储存库标本和数据。39 其中一些出版物还涉及与西雅图以外的组织的合作。

Summary: Specimen and Data Core The proposed Specimen & Data Core will serve several central roles within this highly integrated Program Project: 1) it will consent and enroll all Merkel cell carcinoma (MCC) patients into our longitudinal research study; 2) it will acquire, process, and store all patient blood and tumor tissue and distribute them to the relevant Projects and the Immunophenotyping Core; and 3) it will obtain patient clinical data over time, and store research-derived patient results, annotating the samples with corresponding disease status. The proposed Core will expand both our existing MCC Specimen Repository that has over 20,000 individual specimens from 1,400 patients (as of May 2018) and our Relational Database that annotates those samples and patient demographics using approximately 200 data fields including clinical treatments, disease status, and response data, as well as research laboratory results. A proposed, essential new role for the Specimen and Data Core will be to acquire tumor samples (including biopsies obtained for research purposes, rather than only those that were clinically required) from patients before and after PD-1 checkpoint blockade therapy. Obtaining such tissues is complex and laborious but also essential for understanding the basis of response and non-response to these important new immune therapies. An expansion of our Relational Database will involve the addition of over 30 fields to capture new immunotherapy-related results and experimental data that will be useful for the Projects as well as for the Immunophenotyping Core and Biostatistics & Bioinformatics Core. The Specimen and Data Core will also track MCPyV oncoprotein antibody titers to assist in a) detecting early disease recurrence, b) understanding how to use this recently developed test in patients undergoing PD-1 checkpoint blockade therapy, and c) assisting Project 3 in understanding the biological basis of why these antibodies rapidly fall when tumor is removed. Lastly, the Specimen & Data Core will leverage these precious resources by sharing samples and data with the broader MCC and scientific communities through collaborative studies that have proven extremely productive in the past, with 43 publications (through May 2018) that have made use of repository specimens and data. 39 of those publications have also involved collaborations with groups outside of Seattle.