Integrative Clinical and Biospecimen (IBC)

具体目标 芝加哥大学（U芝加哥）消化系统疾病研究核心中心（DDRCC）跨学科- 一项关于炎症性肠病（C-IID）的研究发现， 复杂性胃肠道疾病的临床表现、表型、流行病学和病理生理学研究现状 (GI)需要对临床数据、人体细胞、组织和组织病理学标本进行分析。在- 整合临床和生物样本（ICB）核心，以前称为整合翻译核心（ITR）， 通过提供基础设施和服务来无缝整合临床信息， 生物标本的信息。自上次续约以来，ICB核心一直在努力优化咨询服务， 为人类研究设计提供服务，创建一个动态机制来访问临床数据， 为患者和生物样本招募提供高效的工作流程。所有改进都得到了芝加哥大学的支持。 并作为其他C-IID核心的关键资源。此外，自上次更新以来，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在 ICB核心，以解决先前的批评，即没有直接监督的病理学家的生物规格， 建立组织库，并向C-IID成员提供关于如何收集、储存和分析的咨询服务 生物标本 自2015年以来，47个C-IID成员（占成员总数的66%）使用了ICB核心。6034例患者 同意参加ICB核心登记研究，所有GI研究共招募了8382例患者， 在过去的5年里。ICB核心还建立了一个生物标本储存库，以促进快速分类， 数据的收集，包括1800多名患者的30，000多份生物标本，包括全血DNA， 朗姆酒、活组织检查RNA和DNA、快速冷冻肠活组织检查样本、肝活组织检查和福尔马林固定石蜡 包埋（FFPE）组织。此外，ICB还植入了一个基础设施，以协助进行前瞻性筛选- 个体研究者转化研究的筛选、招募和样本采集。ICB核心将与- 继续在过去5年建立的基础设施基础上进行建设，以满足不断增长和变化的需求， 满足C-IID研究者对临床数据库信息和良好表型生物标本的需求。 ICB核心的具体目标如下： 1.为基于人体生物等效性的研究设计提供咨询服务。ICB核心利用 核心主任的人类转化和基础科学专业知识，以促进以人为本的研究：a） 提供咨询服务，以开发和推进转化研究实验设计，以促进 提交独立审查报告，并促进统计分析;以及B）提供咨询服务， 病理标本和服务。 2.提供基础设施和服务，以优化临床数据库的使用。ICB核心提供 简化了对全面临床信息的访问，作为患者招募，表型分析， 和流行病学数据：a）维护一个虚拟临床数据库， 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）提供服务以询问虚拟临床数据库tai中的数据， 满足调查人员的需求。 3.提供病理咨询及组织病理学分析。ICB的一个重要组成部分 核心是提供病理学咨询，指导所有技术，包括免疫组织化学和 专门指导，具体涉及复杂的胃肠道疾病的分析。核心也是亲- vides免疫组织化学或免疫荧光染色的收费服务， 来自人类和动物的组织。该子目标旨在满足以下所有最常用的方面： 组织和细胞分析（TCA）核心。 4.为生物标本利用提供基础设施和服务。ICB Core提供统一的页面- 通过以下方式进行人才招募和生物样本获取，以优化个人和合作研究：a）保持- 雇用工作人员以确保预期的患者招募、生物标本采集和处理; B）维持 生物标本库，在表型良好的群体中具有大量不同的样品; c）建立 标准操作程序和最佳做法，以实现最佳的采购和储存;以及d）使利用率- 病理学档案和组织病理学处理的转化研究。 ICB核心的最终目标是保持一个不可或缺的，重要的资源，促进transla， 了解复杂气体的生理学、发病机制和未来治疗发展的基础研究， 胃肠疾病

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