Core 2: Clinical and Tissue Core

项目摘要(核心2) 现代生物医学研究正在被越来越多的信息洪流所改变。 电子病历为研究广泛的疾病打开了前所未有的机会 从人类疾病的流行病学方面到各种药物的比较有效性等问题 治疗方案。同样，下一代DNA和RNA测序等基因组技术也具有 打开了一扇数据和信息的闸门，有望揭示人类的复杂性 疾病。在这个信息丰富的时代，最大的挑战之一因此不再是生成数据，而是 有效地将其整合起来，使其能够发挥优势。因为临床实践长期以来是分开的 从大多数学术卫生中心的研究企业来看，临床和 研究数据存在于独立的、通常不兼容的领域，具有各种技术、机构和 他们之间的组织障碍。进一步限制了我们提取数据的最大值的能力 可用的事实是，机构内部的数据很少与 公有领域。同样，另一个需要是帮助研究人员更好地描述和识别肿瘤生物学 和分子遗传与反应、进展和生存相关，通过收集、保存和 按照临床方案分发来自患者的组织。将使用大量的临床数据来源 计划项目。这项大型IFM/DFCI合作临床试验的数据(1260名MM患者，如下 诱导HDT和巩固，达到最小残留病将来那度胺随机加用 或不使用daratumumab)收集在IFM和DFCI已建立的临床试验数据库中。目标 核心B的任务是创建、维护和质量控制临床数据库(具体目标1)； 使用标准化程序集中运输、处理和存储来自所有站点的组织样本 组织库(具体目标2)；并开发一个综合数据库，将样本跟踪和 通过基于Web的查询从临床试验数据库中获取相关临床数据的癌基因组信息 能力(具体目标3)。

Project Summary (Core 2) Modern biomedical research is being transformed by what is increasingly becoming a flood of information. Electronic medical records have opened unprecedented opportunities for studies investigating a wide range of problems ranging from epidemiological aspects of human disease to the comparative effectiveness of various treatment protocols. Similarly, genomic technologies such as next-generation DNA and RNA sequencing have opened a floodgate of data and information that promises to shed light on the complex nature of human disease. In this information-rich age, one of the greatest challenges is therefore no longer generating data, but effectively integrating it so that it can be used to advantage. Because clinical practice has long been separate from the research enterprise at most academic health centers, a situation has evolved in which clinical and research data exist in separate, often incompatible domains with a variety of technical, institutional, and organizational barriers between them. Further limiting our ability to extract the maximal value of the data we have available is the fact that data within institutions is rarely integrated with the vast body of data available in the public domain. Similarly, another need is to aid Investigators better characterize and identify tumor biologic and molecular genetic correlates for response, progression, and survival by collecting, preserving and distributing tissue derived from patients on clinical protocol. A large sources of clinical data will be used in this program project. The data for this large IFM/DFCI collaborative clinical trials (1260 MM patients, following induction HDT and consolidation, achieving minimal residual disease will be randomized to lenalidomide with or without daratumumab) are collected in an established clinical trials database at the IFM and DFCI. The aims of Core B are to create, maintain, and quality control the clinical database (Specific Aim 1); to collect, transport, process and store tissue samples from all sites utilizing standardized procedures in centralized tissue banks (Specific Aim 2); and to develop an integrated database to integrate the sample tracking and oncogenomic information with the relevant clinical data from the clinical trials database with web based query capabilities (Specific Aim 3).