Clinical Core

临床核心

• 批准号: 10048895
• 负责人: Ramnik J Xavier
• 金额: $ 19.56万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-01-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10048895
• 关键词: Algorithms; Applications Grants; Basic Science; Bioinformatics; Biological Markers; Biological Response Modifier Therapy; Biopsy; Blood specimen; Cells; Clinical; Clinical Data; Clinical Research; Clinical Trials; Clostridium difficile; Cohort Analysis; Collaborations; Collection; Colonoscopy; Communities; Computerized Medical Record; Consultations; Crohn' s disease; DNA Library; Data; Data Analyses; Data Collection; Databases; Diagnosis; Diet; Disease; Disease Outcome; Disease Progression; Early Diagnosis; Endoscopy; Enrollment; Environment; Environmental Exposure; Evaluation; Event; Fatigue; Feces; Gastrointestinal Diseases; Gene Cluster; General Hospitals; Genetic; Genomics; Genotype; Health; Human; Human Genetics; Human Microbiome; Individual; Infection; Inflammatory Bowel Diseases; Infrastructure; Institutes; Institution; Intervention; Laboratory Finding; Laboratory Research; Libraries; Life; Link; Longitudinal cohort; Maps; Massachusetts; Mental Depression; Metadata; Metagenomics; Methods; Molecular; Monitor; Natural Language Processing; Patients; Phenotype; Physicians; Probiotics; Prospective cohort; Protocols documentation; Publications; Reference Values; Registries; Research; Research Design; Research Personnel; Research Support; Resources; Role; Sampling; Scientist; Serum; Services; Site; Symptoms; Testing; Therapeutic; Tissue Sample; Tissues; Training; Training and Education; Translating; Translations; Ulcerative Colitis; Urine; Variant; base; biobank; clinical database; cohort; disease diagnosis; disease phenotype; efficacy study; fecal metabolome; fecal microbiome; fecal transplantation; gene function; genomic data; genomic locus; genotyped patients; improved; in silico; in vivo; insight; interest; knowledge base; metabolomics; metatranscriptomics; microbial; microbiome; phenotypic data; prognostic; prospective; rare variant; relapse prediction; repository; research study; response; risk stratification; success; tool; transcriptome sequencing; translational study; treatment optimization

CLINICAL CORE: PROJECT SUMMARY The Clinical Core will be led by Ramnik Xavier (Director), Andrew Chan (Co-Director), and Ashwin Ananthakrishnan (Technical Director). Core services are organized into (1) consultation, training, and education, including advice on research study design, execution, and analysis as well as education and training of junior investigators, residents, and fellows; (2) biospecimen services, including clinical database and patient identification, biospecimen collection and processing, and serum, stool, and tissue biorepository services; (3) data collection and analysis, including regulatory services, a genotype and microbiome library, RNA-sequencing from colonic biopsies, and bioinformatics support; and (4) access to a clinical and translational database, including detailed phenotyping and clinical data linked to each patient’s genotype and microbiome features. Central components of the Clinical Core are two patient cohorts: the Prospective Registry in IBD Study at MGH (PRISM) and the GI Disease and Endoscopy Registry (GIDER). By obtaining pre- and post-event samples, these cohorts are anchored around disease extension, new diagnosis, and institution of specific biologic treatments that provide evolving clinical metadata and serial biospecimens. With more than 3,200 patients enrolled, PRISM now collects biospecimens for metagenomic, metatranscriptomic, and metabolomic analyses as well as information on early life environmental exposures, fatigue, depression, and diet. The Core recently introduced GIDER, a longitudinal colonoscopy-based cohort with 800 healthy individuals enrolled to date that will enhance our understanding of genetic, microbial, and environmental determinants across a spectrum of gastrointestinal diseases. This core serves as a hub for interactions between clinicians and basic researchers, allowing scientists to test hypotheses in human samples and clinicians to gain valuable insight into disease states. The specific aims of the Clinical Core are to (1) build a biorepository of patients with Crohn’s disease and ulcerative colitis with accurate phenotyping of disease as well as sampling of blood, stool, urine, and tissue in various disease states (active/inactive disease) and related to various therapeutic and environmental perturbations; (2) develop and expand longitudinal cohorts of health and disease anchored around disease diagnosis, prediction of relapse, and response to specific therapies in patients with IBD; (3) define the phenotypic implications of genetic loci and microbial perturbations with regard to clinical manifestations, response to therapy, and to examine the interaction with the environment; (4) facilitate education and training in research by providing consultations regarding study design, methods, and analysis as well as attract new investigators to the field through these services; and (5) translate laboratory and clinical research findings into interventions that improve diagnosis, develop biomarkers for disease monitoring and prognostication, and optimize treatment algorithms.

临床核心：项目摘要 临床核心将由 Ramnik Xavier（主任）、Andrew Chan（联合主任）和 Ashwin 领导 Ananthakrishnan（技术总监）的核心服务分为 (1) 咨询、培训和 教育，包括研究设计、执行和分析以及教育和培训方面的建议 (2)生物样本服务，包括临床数据库和患者 鉴定、生物样本采集和处理以及血清、粪便和组织生物储存库服务 (3) 数据收集和分析，包括监管服务、基因型和微生物组库、RNA 测序 来自结肠活检和生物信息学支持；以及 (4) 访问临床和转化数据库， 包括与每位患者的基因型和微生物组特征相关的详细表型和临床数据。 临床核心的核心组成部分是两个患者队列： MGH 的 IBD 研究前瞻性登记 （PRISM）和胃肠道疾病和内窥镜检查登记处（GIDER）通过获取事件前和事件后样本，这些。 队列以疾病扩展、新诊断和特定生物治疗机构为中心 PRISM 已招募了 3,200 多名患者，提供不断发展的临床元数据和系列生物样本。 现在收集生物样本用于宏基因组、宏转录组和代谢组分析以及 The Core 最近推出了有关早期生活环境暴露、疲劳、抑郁和饮食的信息。 GIDER，一个基于纵向结肠镜检查的队列，迄今为止已招募 800 名健康个体，这将增强 我们对一系列胃肠道疾病的遗传、微生物和环境决定因素的理解 疾病。 该核心充当忠诚者和基础研究人员之间互动的中心，使科学家能够测试 对人类样本和人群进行假设，以获得对疾病状态的有价值的见解。 临床核心是 (1) 建立克罗恩病和溃疡性结肠炎患者的生物样本库 准确的疾病表型分析以及各种疾病状态下的血液、粪便、尿液和组织取样 （活动性/非活动性疾病）并与各种治疗和环境扰动相关；（2）发展和 扩大围绕疾病诊断、复发预测的健康和疾病的纵向队列， 以及 IBD 患者对特定治疗的反应；(3) 定义遗传位点的表型影响和 与临床表现、治疗反应有关的微生物扰动，并检查相互作用 (4) 通过提供研究咨询来促进研究教育和培训 设计、方法和分析，并通过这些服务吸引新的研究人员进入该领域；(5) 将实验室和临床研究结果转化为改善诊断、开发生物标志物的干预措施 用于疾病监测和预后，并优化治疗算法。