Core 1: Specimen and Data Core

核心 1：样本和数据核心

基本信息

批准号：
10629194
负责人：
PAUL NGHIEM
金额：
$ 33.34万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-04-04 至 2025-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10629194
关键词：
Antibodies Antibody titer measurement B-Lymphocytes Bioinformatics Biological Biological Markers Biological Specimen Banks Biology Biometry Biopsy Blood Blood specimen Caring Cells Clinical Clinical Data Clinical Research Clinical Treatment Collaborations Collection Communities Complex Consent Data Databases Disease Early Diagnosis Enrollment Ensure Guidelines Immune Immunobiology Immunologic Markers Immunooncology Immunophenotyping Immunotherapy Individual Institution Interest Group International Laboratories Laboratory Research Link Longitudinal Studies Medical Merkel Cells Merkel cell carcinoma National Comprehensive Cancer Network Oncoproteins Outcome PD-1 blockade Patient-Focused Outcomes Patients Polyomavirus Process Productivity Publications Qualifying Recommendation Recurrence Recurrent disease Research Resource Sharing Resources Role Sampling Scientist Serology test Specimen Testing Time Tissues Translational Research Tumor Antibodies Tumor Burden Tumor Tissue burden of illness chemotherapy cohort data repository demographics exome sequencing falls immune checkpoint blockade improved insight multidimensional data participant enrollment programmed cell death protein 1 programs relational database repository research clinical testing research study response transcriptome sequencing transcriptomics tumor

项目摘要

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.

摘要：样本和数据核心拟议的样本和数据核心将在这个高度集成的计划中发挥几个核心作用项目：1）它将同意并将所有默克尔细胞癌（MCC）患者纳入我们的纵向研究学习; 2）它将采集、处理和存储所有患者血液和肿瘤组织，并将其分发给相关部门项目和免疫表型核心； 3）它将随着时间的推移获取患者的临床数据，并存储研究得出的患者结果，用相应的疾病状态注释样本。拟议的 Core 将扩展我们现有的 MCC 标本存储库，该存储库拥有超过 20,000 个来自 1,400 名患者（截至 2018 年 5 月）以及我们注释这些样本和患者的关系数据库使用大约 200 个数据字段（包括临床治疗、疾病状态和反应）进行人口统计数据以及研究实验室结果。拟议的样本和数据核心的重要新作用将是获取肿瘤样本（包括出于研究目的从患者身上获取的活检，而不仅仅是临床所需的活检 PD-1检查点阻断治疗之前和之后。获得这种组织既复杂又费力，而且对于了解这些重要的新型免疫疗法的反应和无反应的基础至关重要。我们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疗法相关的结果和实验数据将对项目以及免疫表型分析核心和生物统计学与生物信息学核心。样本和数据核心也将跟踪 MCPyV 癌蛋白抗体滴度可协助 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一最近开发的测试，以及 c) 协助项目 3 了解肿瘤切除后这些抗体迅速下降的生物学基础。最后，样本和数据核心将通过与样本和数据共享来利用这些宝贵的资源。通过已被证明极其富有成效的合作研究，更广泛的 MCC 和科学界过去，有 43 篇出版物（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团体的合作。