Integrative Clinical and Biospecimen (IBC)

综合临床和生物样本 (IBC)

基本信息

批准号：
10548864
负责人：
Sonia Kupfer
金额：
$ 15.31万
依托单位：
UNIVERSITY OF CHICAGO
依托单位国家：
美国
项目类别：
财政年份：
1996
资助国家：
美国
起止时间：
1996-12-01 至 2025-11-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10548864
关键词：
Address Archives Basic Science Behavior Biological Specimen Banks Biopsy Biopsy Specimen Cells Cessation of life Chicago Clinical Clinical Data Clinical Investigator Complex Consent Consultations DNA Data Digestive System Disorders Ensure Epidemiology Experimental Designs Fee-for-Service Plans Formalin Foundations Freezing Functional disorder Future Gastrointestinal Diseases Generations Goals Histopathology Human Immunohistochemistry Implant Individual Inflammatory Bowel Diseases Infrastructure Institutional Review Boards Instruction Interdisciplinary Study Intestines Metadata Paraffin Embedding Pathogenesis Pathologist Pathology Patient Recruitments Patients Phenotype Physiology Population Procedures RNA Registries Research Research Design Research Personnel Resources Sampling Serum Services Source Specimen Stains Statistical Data Interpretation Techniques Tissue Banks Tissue Embedding Tissues Translational Research Universities Whole Blood Work animal tissue clinical database epidemiologic data gastrointestinal human study human tissue improved liver biopsy member neoplasm registry phenotypic data prospective recruit sample collection screening service utilization therapeutic development translational scientist translational study virtual

项目摘要

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

具体目标芝加哥大学 (UChicago) 跨学科消化疾病研究核心中心 (DDRCC) 炎症性肠病 (C-IID) 的多项研究研究人员认识到，全面的欠复杂胃肠道的临床行为、表型、流行病学和病理生理学的现状 (GI) 疾病需要分析临床数据、人体细胞、组织和组织病理学标本。在- 整合临床和生物样本 (ICB) 核心，以前称为综合转化核心 (ITR)，通过提供基础设施和服务来无缝集成临床信息来促进转化研究与生物样本的结合。自上次更新以来，ICB 核心一直坚定不移地优化咨询服务人类研究设计服务，创建动态机制来访问临床数据并创建患者和生物样本招募的高效工作流程。所有改进均得到芝加哥大学的支持并充当其他 C-IID 核心的关键资源。此外，自上次续订以来，我们认识到通过组织细胞分析 (TCA) 核心提供的服务将更合理地放置在 ICB Core 为了解决之前的批评，即没有病理学家对生物特异性进行直接监督 imen 组织库，并向 C-IID 会员提供如何收集、存储和分析的咨询服务生物样本。自 2015 年以来，已有 47 个 C-IID 成员（占会员总数的 66%）使用了 ICB 核心。已治疗6034名患者同意 ICB 核心注册，通过 ICB 核心招募了总共 8382 名患者进行所有 GI 研究。过去 5 年。 ICB 核心还建立了生物样本库，以促进快速生成数据化，包括 1800 多名患者的 30,000 多个生物样本，包括全血 DNA、se- 朗姆酒、活检 RNA 和 DNA、快速冷冻肠活检样本、肝活检和福尔马林固定石蜡包埋（FFPE）组织。此外，ICB 还植入了基础设施来协助前瞻性筛选—— 个体研究者转化研究的筛选、招募和样本收集。 ICB核心将继续继续以过去五年建立的基础设施为基础，以满足不断增长和变化的需求满足 C-IID 研究人员对临床数据库信息和表型良好的生物样本的需求。 ICB 核心的具体目标如下： 1. 为基于人体生物样本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，通过以下方式促进以人为本的研究：a) 提供咨询服务来开发和推进转化研究实验设计，以促进提交IRB并促进统计分析； b) 提供利用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 核心提供简化对综合临床信息的访问，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数据，包括 Epic、Centricity、国家死亡登记处、癌症登记处尝试 LabVantage 和 REDCap； b) 提供查询虚拟临床数据库中数据的服务满足调查员的需要。 3.提供病理咨询和组织病理学分析。 ICB的重要组成部分核心是提供病理学咨询、所有技术的指导，包括免疫组织化学和专门与复杂胃肠道疾病分析相关的专业指导。该核心还亲提供研究者提供的或存档的按服务收费的免疫组织化学或免疫荧光染色衍生的人类和动物组织。该子目标旨在满足所有最常用的方面我们之前的组织和细胞分析 (TCA) 核心。 4. 提供生物标本利用的基础设施和服务。 ICB核心提供统一的pa- 人才招募和生物样本采集，通过以下方式优化个人和协作研究：a) 维护- 培训工作人员以确保未来的患者招募、生物样本采集和处理； b) 维持生物样本库，拥有大量表型良好的不同样本； c) 建立标准操作程序和最佳实践，以实现最佳采集和存储； d）使利用用于转化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领域不可或缺的重要资源。了解复杂气体的生理学、发病机制和未来治疗发展的国际研究肠肠疾病