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
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