Core 1: Specimen and Data Core

核心 1：样本和数据核心

基本信息

批准号：
10380821
负责人：
PAUL NGHIEM
金额：
$ 35.06万
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 2024-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10380821
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 Outcomes Research PD-1 blockade Patient-Focused Outcomes Patients Polyomavirus Process Publications Recurrence Research Resource Sharing Resources Role Sampling Scientist Serology test Specimen Testing Time Tissues Translational Research Tumor Antibodies Tumor Burden Tumor Tissue base 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 therapy outcome transcriptome sequencing transcriptomics treatment response 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：标本和数据核心拟议的标本和数据核心将在此高度集成的程序中扮演多个核心角色项目：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）它将获取，处理和存储所有患者血液和肿瘤组织，并将其分配给相关项目和免疫表型核心； 3）随着时间的流逝，它将获得患者的临床数据，并存储研究衍生的患者结果，注释具有相应疾病状态的样本。提议核心将扩大我们现有的MCC标本存储库，该存储库有超过20,000个单独的标本 1,400名患者（截至2018年5月）和我们的关系数据库注释这些样品和患者人口统计使用了大约200个数据领域，包括临床治疗，疾病状况和反应数据以及研究实验室结果。标本和数据核心的提出的重要新作用将是获取肿瘤样本（包括为了研究目的而获得的活检，而不仅仅是临床要求的活检） PD-1检查点封锁治疗之前和之后。获得此类组织是复杂而费力的，但也对这些重要的新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增加30多个字段以捕获新的免疫疗法相关的结果和实验数据将对项目以及免疫表型核心和生物统计学和生物信息学核心。标本和数据核心也将跟踪 MCPYV癌蛋白抗体滴度有助于a）检测早期疾病复发，b）了解如何使用此最近开发的在接受PD-1检查点阻滞疗法的患者中的测试，c）协助在理解为什么这些抗体在切除肿瘤时迅速下降的生物学基础的项目3。最后，标本和数据核心将通过与通过合作研究，更广泛的MCC和科学社区已证明非常有生产力过去，有43个出版物（截至2018年5月）使用了存储库标本和数据。 39 这些出版物中还涉及与西雅图以外的团体的合作。