Core 2 - Clinical Core

核心 2 - 临床核心

• 批准号: 9370750
• 负责人: Peter Izmirly
• 金额: $ 18.72万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9370750
• 关键词: Accounting; Address; Age; Asians; Autoantibodies; Autoimmunity; B-Lymphocytes; Blood; Center for Translational Science Activities; Child; Clinic; Clinical; Clinical Data; Collection; Coupled; Data; Data Analyses; Databases; Diagnosis; Disease; Disease remission; Enrollment; Ethnic Origin; Ethnic group; Event; Feces; Flare; Foundations; Gender; Genetic; Goals; Health Status; Hispanics; Hospitals; Indigent; Insurance; Kidney Diseases; Link; Lupus; Managed Care; Methodology; Molecular; Molecular Profiling; Mothers; Nature; Neonatal lupus erythematosus; New York; Pathogenesis; Pathway interactions; Patients; Pharmaceutical Preparations; Phenotype; Population; Positioning Attribute; Pregnancy; Private Practice; Protocols documentation; Race; Recruitment Activity; Registries; Research; Research Design; Research Personnel; Research Project Grants; Resources; Rheumatology; Risk; SS-A antibodies; Sampling; Scientist; Source; Specimen; Symptoms; Systemic Lupus Erythematosus; T-Lymphocyte; Technology; Testing; Twin Multiple Birth; Universities; Variant; Woman; arthropathies; base; biobank; clinical phenotype; cohort; design; experimental study; follow-up; instrument; medical schools; microbiome; offspring; pre-clinical; prospective; racial and ethnic; repository; sex; success

ABSTRACT Understanding Systemic Lupus Erythematosus (SLE) presents a formidable challenge to both the basic scientist and the clinician, given its undulating and often unpredictable course, variability among different racial/ethnic groups, and dearth of approved medications. The Clinical Core of the Translational Center of Molecular Profiling in Preclinical and Established Lupus will be the foundation for three Research Projects that focus on molecular comparisons and contrasts between clinically asymptomatic and symptomatic autoimmunity to elucidate protective, inciting, and perpetuating events in the pathogenesis of SLE. The Clinical Core will leverage access to two unique sources of patient material: 1) the Research Registry for Neonatal Lupus (RRNL), which provides a rare opportunity to study asymptomatic women at risk for developing SLE who are identified to have anti-Ro antibodies solely based on the diagnosis of neonatal lupus in an offspring; 2) the NYU Lupus Cohort, a large well-characterized prospective multiracial/ethnic cohort; and 3) healthy controls age, ethnically/racially, and gender matched to subjects. The Clinical Core will provide detailed phenotypic analysis of these two cohorts by linking clinical data inclusive of validated disease activity and flare instruments specific to Lupus to precisely define timing of flares and remissions with biologic inquiries related to genetics, the microbiome, B and T cells, and autoantibody profiles. These goals will be accomplished via three specific aims: Specific Aim 1 will develop and maintain a clinical database and linked sample repository comprised of mothers enrolled in the RRNL and a prospectively followed cohort of subjects with overt SLE. Clinical data will be matched with subject blood and stool samples (specific to the needs of the Research Projects), which will be stored and maintained by the Clinical Core. Specific Aim 2 will establish a workflow for the delivery of specimens and linked clinical data to investigators in Projects 1, 2, and 3 with sample procurement coordinated to provide both fresh and stored specimens driven by the research protocols. Specific Aim 3 will incorporate appropriate statistical resources to perform analyses correlating research data with matched clinical data. It is anticipated that the Clinical Core will provide an unprecedented platform upon which state-of-the-art technologies can be applied to precisely phenotyped and longitudinally followed cohorts.

抽象的 了解系统性红斑狼疮（SLE）对这两种基本的挑战提出了巨大的挑战 科学家和临床医生，鉴于其起伏不定，通常是不可预测的，不同 种族/族裔群体，缺乏批准的药物。转化中心的临床核心 临床前和已建立的狼疮的分子分析将成为三个研究项目的基础 侧重于分子比较和临床无症状和有症状之间的对比 自身免疫性以阐明SLE发病机理中的保护性，煽动和永久性事件。临床 核心将利用访问两个独特的患者材料来源：1）新生儿的研究注册表 狼疮（rrnl），它提供了一个难得的机会来研究有没有发展SLE风险的无症状女性 仅基于后代新生儿狼疮的诊断而被确定为抗罗抗体； 2） 纽约大学狼疮队员，这是一个庞大的特色前瞻性多种族/族裔队列； 3）健康对照 年龄，种族/种族，性别与受试者相匹配。临床核心将提供详细的表型 通过连接临床数据（包括经过验证的疾病活动和耀斑仪器）来分析这两个队列 特定于狼牙 微生物组，B和T细胞以及自身抗体谱。这些目标将通过三个特定的 目的：特定目标1将开发和维护临床数据库和链接样本存储库 由参加RRNL的母亲和前瞻性的受试者组成 sle。临床数据将与受试者血液和粪便样本相匹配（特定于研究的需求 项目），该项目将由临床核心存储和维护。特定目标2将建立工作流程 为了将样品和临床数据链接到项目1、2和3的研究人员，并将样品链接 采购协调以提供由研究方案驱动的新鲜和存储的标本。 特定目标3将包含适当的统计资源以执行分析 研究数据具有匹配的临床数据。预计临床核心将提供 前所未有的平台可以将最先进的技术应用于精确表型和 纵向跟随队列。