Integrative Clinical and Biospecimen (IBC)

具体目标 芝加哥大学消化疾病跨学科研究核心中心(DDRCC) 几乎没有炎症性肠病研究(C-IID)的研究人员认识到，一个全面的低于- 复杂胃肠道疾病的临床表现、表型、流行病学和病理生理的认识 (胃肠道疾病)需要对临床数据、人体细胞、组织和组织病理标本进行分析。在- 综合临床和生物医学(ICB)核心，以前称为综合翻译核心(ITR)，ENA- 通过提供无缝集成临床信息的基础设施和服务来支持转化性研究。 用生物检疫剂进行混合。自上次更新以来，ICB核心一直坚定不移地致力于优化咨询- 为人类研究设计提供服务，创建访问临床数据的动态机制并创建 为患者和生物制品招募提供高效的工作流程。所有改进都得到了UChicago的支持 并作为其他C-IID核心的关键资源。此外，自上次延期以来，我们认识到 通过组织细胞分析(TCA)核心提供的服务将更符合逻辑地放置在 ICB Core，以回应之前关于生物细菌病理学家没有直接监督的批评- Iman组织库，并为C-IID成员提供如何收集、存储和分析的咨询服务 生物群落。 自2015年以来，47个C-IID成员使用了ICB核心，占成员总数的66%。6034名患者已经接受了 同意ICB核心注册，总共有8382名患者通过ICB核心招募参加所有GI研究- 我是在过去的5年里。ICB核心还建立了一个生物标本储存库，以促进快速属- 收集的数据包括1800多名患者的30,000多份生物标本，包括全血DNA、Se-DNA和 朗姆酒，活组织RNA和DNA，快速冷冻的肠道活组织样本，肝活检，福尔马林固定的石蜡切片 包埋(FFPE)组织。此外，ICB还植入了一个基础设施，以帮助进行未来的筛查- 为个别调查员的翻译研究进行ING、招聘和样本收集。ICB的核心将包括- TINUE将在过去5年建立的基础设施基础上再接再厉，以满足不断增长和变化的需求 C-IID研究人员对临床数据库信息和表型良好的生物标本的需求。 ICB核心的具体目标如下： 1.为基于生物样品的研究设计提供咨询服务。ICB核心利用 核心主任的人类翻译和基础科学专门知识，以促进以人为本的研究：a) 提供咨询服务，以开发和推进翻译研究实验设计，以促进 提交IRBs并促进统计分析；以及b)提供咨询服务，以便利用 病理标本和服务。 2.提供基础设施和服务，优化临床数据库的使用。ICB核心提供 简化对全面临床信息的访问，将其作为患者招募、表型鉴定、 和流行病学数据：a)维护无缝集成临床元数据的虚拟临床数据库- 来自内部和外部来源的TA，包括Epic、Centricity、国家死亡登记处、癌症登记处- Try、LabVantage和RedCap；以及b)提供查询虚拟临床数据库TAI中的数据的服务 热衷于调查人员的需要。 3.提供病理咨询和组织病理学分析。ICB的一个重要组成部分 核心是提供病理咨询，指导所有技术，包括免疫组织化学和 专门针对复杂胃肠道疾病的分析的专门指导。核心也支持- 对调查员提供的或档案进行收费的免疫组织化学或免疫荧光染色- 取自人类和动物组织。此子目标旨在满足以下所有使用最频繁的方面 我们之前的组织和细胞分析(TCA)核心。 4.为生物制剂的利用提供基础设施和服务。ICB核心提供统一的页面- Tient招聘和生物谱收购，通过以下方式优化个人和合作研究：a)维护- ING工作人员，以确保未来的病人招募、生物素采集和处理；b)保持 在表型良好的人群中拥有大量不同样本的生物谱系资料库；c)建立 最佳获取和存储的标准操作程序和最佳做法；以及d)实现利用- 翻译研究的病理档案和组织病理学处理。 ICB核心的最终目标是继续成为推动翻译工作不可或缺的重要资源-- 复杂气体中毒的生理、发病机制及未来治疗进展的国内研究 肠道疾病

SPECIFIC AIMS The University of Chicago (UChicago) Digestive Diseases Research Core Center (DDRCC) for Interdiscipli- nary Study of Inflammatory Intestinal Disorders (C-IID) investigators recognize that a comprehensive under- standing of the clinical behavior, phenotype, epidemiology and pathophysiology of complex gastrointestinal (GI) disorders requires analysis of clinical data, human cells, tissues and histopathological specimens. The In- tegrative Clinical and Biospecimen (ICB) Core, formerly called the Integrative Translational Core (ITR), ena- bles translational research by providing the infrastructure and services to seamlessly integrate clinical infor- mation with biospecimens. Since the last renewal, the ICB Core has worked steadfastly to optimize consulta- tion services for human study design, create a dynamic mechanism to access clinical data and to create an efficient workflow for patient and biospecimen recruitment. All improvements are supported by the UChicago and function as a critical resource for the other C-IID Cores. In addition, since the last renewal, we recognize that services provided through the Tissue Cell Analysis (TCA) Core would more logically be placed within the ICB Core in order to address previous criticism that there is no direct oversight by a pathologist of the biospec- imen tissue bank and to provide consultation services to C-IID members on how to collect, bank and analyze biospecimens. Since 2015, 47 C-IID members, 66% of membership, have utilized the ICB Core. 6034 patients have been consented to the ICB Core Registry with a total of 8382 patients recruited through the ICB Core for all GI stud- ies in the past 5 years. The ICB Core has also built a repository of biospecimens to facilitate the rapid genera- tion of data which includes over 30,000 biospecimens on over 1800 patients, including whole blood DNA, se- rum, biopsy RNA and DNA, flash frozen intestinal biopsy samples, liver biopsies, and formalin-fixed paraffin embedded (FFPE) tissues. In addition, the ICB has implanted an infrastructure to assist in prospective screen- ing, recruitment, and sample collection for individual investigator's translational studies. The ICB core will con- tinue to build on the infrastructural foundation established over the last 5 years to meet the growing and chang- ing needs of C-IID investigators for clinical database information and well-phenotyped biospecimens. The Specific Aims of the ICB Core are as follows: 1. To provide consultative services for human biospecimen-based study design. The ICB Core utilizes human translational and basic science expertise of the Core directors to facilitate human-based studies by: a) providing consultative services to develop and advance translational study experimental design, to facilitate submission of IRBs and to facilitate statistical analyses; and b) providing consultative services for utilization of pathology specimens and services. 2. To provide infrastructure and services to optimize clinical database use. The ICB Core provides streamlined access to comprehensive clinical information as a resource for patient recruitment, phenotyping, and epidemiology data by: a) maintaining a virtual clinical database that seamlessly integrates clinical metada- ta from internal and external sources including Epic, Centricity, the National Death Registry, the Cancer Regis- try, LabVantage, and REDCap; and b) providing services to interrogate data in the virtual clinical database tai- lored to investigator needs. 3. To provide pathology consultation and histopathological analysis. An important component of the ICB Core is to provide pathology consultation, instruction in all techniques, including immunohistochemistry and specialized guidance specifically related to the analysis of complex gastrointestinal disease. The core also pro- vides fee-for-service immunohistochemical or immunofluorescent staining of investigator-provided or archive- derived human and animal tissue. This sub-aim is intended to satisfy all of the most heavily used aspects of our previous Tissue and Cell Analysis (TCA) Core. 4. To provide infrastructure and services for biospecimen utilization. The ICB Core provides uniform pa- tient recruitment and biospecimen acquisition to optimize individual and collaborative research by: a) maintain- ing staff to ensure prospective patient recruitment, biospecimen acquisition and processing; b) maintaining a biospecimen repository with a large number of diverse samples in well-phenotyped populations; c) establishing standard operating procedures and best practices for optimal acquisition and storage; and d) enabling utiliza- tion of pathology archives and histopathology processing for translational research. The ultimate goal of the ICB Core is to remain an integral, essential resource for the advancement of transla- tional research in understanding physiology, pathogenesis and future therapeutic development in complex gas- trointestinal disorders