Core 2: Clinical and Tissue Core

核心 2：临床和组织核心

• 批准号: 10226187
• 负责人: herve Avet loiseau
• 金额: $ 16.97万
• 依托单位: DANA-FARBER CANCER INST
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-12-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10226187
• 关键词: Age; Architecture; Biological; Biological Specimen Banks; Biomedical Research; Blood specimen; Bortezomib; Cells; Clinical; Clinical Data; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Database; Collection; Complex; Computerized Medical Record; Confidential Information; DNA; DNA Microarray Chip; DNA sequencing; Dana-Farber Cancer Institute; Data; Data Analyses; Data Sources; Data Store; Databases; Dexamethasone; Dose; Epidemiology; Floods; Funding; Future; Genomics; Goals; Health; Human Characteristics; Institution; Intuition; Light; Link; Modernization; Molecular Genetics; Monoclonal gammopathy of uncertain significance; Multiple Myeloma; Online Systems; Patients; Plasma; Procedures; Process; Public Domains; Quality Control; RNA; Randomized; Research; Research Personnel; Research Support; Residual Neoplasm; Resources; Sampling; Secure; Serum; Site; Source; Standardization; Structure; System; Technology; Tissue Banks; Tissue Sample; Tissues; Training; Transplantation; Transport Process; Treatment Protocols; Work; cancer genomics; central database; clinical database; clinical practice; clinically relevant; comparative effectiveness; complex data; data integration; data resource; graphical user interface; human disease; lenalidomide; next generation; preservation; programs; prototype; response; transcriptome sequencing; tumor; web portal

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).

项目摘要（核心2） 现代生物医学研究正在被日益成为信息洪流的东西所改变。 电子医疗记录为研究广泛的疾病提供了前所未有的机会。 从人类疾病的流行病学方面到各种疾病的比较有效性， 治疗方案。同样，基因组技术，如下一代DNA和RNA测序， 打开了一扇数据和信息的闸门，有望揭示人类复杂的本质。 疾病因此，在这个信息丰富的时代，最大的挑战之一不再是生成数据， 有效地整合它，以便它可以被利用。因为临床实践长期以来 从大多数学术健康中心的研究企业，一种情况已经演变，其中临床和 研究数据存在于独立的，往往不兼容的领域与各种技术，机构， 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， 一个令人遗憾的事实是，机构内的数据很少与机构内现有的大量数据相结合， 公共领域。同样，另一个需要是帮助研究者更好地表征和识别肿瘤生物学特性， 和分子遗传相关的反应，进展和生存，通过收集，保存和 根据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， 程序项目。该大型IFM/DFCI合作临床试验的数据（1260例MM患者， 诱导HDT和巩固，达到最小残留疾病，将随机接受来那度胺， 或不使用达雷妥尤单抗）收集在IFM和DFCI的已建立的临床试验数据库中。目标 核心B是创建、维护和质量控制临床数据库（具体目标1）;收集， 采用标准化程序集中运输、处理和储存来自所有研究中心的组织样本 组织库（具体目标2）;以及开发一个综合数据库， 肿瘤基因组信息和来自临床试验数据库的相关临床数据，基于Web的查询 具体目标（3）。