Core 1: Sample Procurement and Clinical Core

核心1：样品采购和临床核心

• 批准号: 10222318
• 负责人: John D Roback
• 金额: $ 53.03万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10222318
• 关键词: 2019-nCoV; Address; African American; Age; Aliquot; Ambulatory Care Facilities; Anemia; Archives; Autoimmunity; Blood; Blood specimen; COVID-19; COVID-19 pandemic; Cancer Patient; Charge; Clinic; Clinical; Clinical Investigator; Clinical Research; Collection; Communicable Diseases; Consent; Databases; Disease; Enrollment; Environment; Freezing; Funding; Goals; Healthcare; Hematological Disease; Hospitals; Iatrogenesis; Immunologic Monitoring; Individual; Infection; Institutes; Institution; Institutional Review Boards; Investigation; Label; Laboratories; Leadership; Location; Logistics; Malignant Neoplasms; Malignant neoplasm of lung; Metadata; Multiple Myeloma; Nurses; Oncology; Participant; Pathologist; Patient Recruitments; Patients; Peripheral Blood Mononuclear Cell; Plasma; Population; Population Programs; Publishing; RNA; Research; Research Activity; Research Personnel; Reverse Transcriptase Polymerase Chain Reaction; Rheumatoid Arthritis; Rheumatology; Sampling; Sampling Studies; Schedule; Secure; Serologic tests; Serum; Services; Site; Specialist; Specimen; Systemic Lupus Erythematosus; Target Populations; Test Result; Testing; Training; Venipunctures; Venous blood sampling; Whole Blood; acute infection; biobank; clinical investigation; data mining; database design; database query; demographics; design; high risk; immunoregulation; interest; meetings; patient population; programs; prospective; recruit; repository; research clinical testing; sample collection

Abstract: The proposed Sample Procurement and Clinical Core (SPCC; Core 1) has been designed to provide a unified, comprehensive, and centralized service for collecting patient samples (both retained clinical specimens and prospectively collected blood samples) to support the studies of Projects 1-3 and Core 2. The SPCC is an outgrowth of similar (unfunded) activities initiated, optimized, and expanded beginning in February 2020, at beginning of the COVID-19 pandemic. The SPCC will coordinate IRB applications, study participant recruitment, sample procurement (including operationalizing blood collections by hospital phlebotomists to reduce venipunctures per patient and PPE use), sample processing, and sample distribution to Projects 1-3 and Core 2. SPCC activities will be performed by regulatory specialists, clinical investigators (from rheumatology, oncology, hematology, and infectious diseases), clinical pathologists, nurse-coordinators, and trained technicians. This group’s efforts will be coordinated through regular meetings between leadership of the 3 Projects, Core 2, and the Administrative Core. The SPCC activities will achieve the following Specific Aims: Aim 1: To extend our existing retained clinical sample repository to support prospective serosurveillance for the target populations of this Program. The SPCC will expand our existing retained sample repository by specifically targeting samples from patients of interest to this Program (eg, systemic lupus erythematosus [SLE]). The resulting longitudinal biorepository will support detailed serial serosurveillance studies by Core 2. Aim 2: To coordinate all regulatory, recruitment, sample procurement, processing, distribution, and storage activities for prospective blood collections required for Projects 1-3. SPCC investigators will maintain comprehensive IRB approval(s) for prospective collection of clinical samples. They will closely collaborate with investigators from all Projects to consolidate sample needs, and develop a schedule for efficient sample collections to meet the needs of Projects 1-3. Staff will coordinate collections, assign sample study numbers, aliquot and label samples, and then either distribute to investigators from individual Projects or store frozen until needed. Samples and patient metadata will be entered into a secure RedCap database. This Core allows U54 investigators to take optimal advantage of unique strengths at Emory including large populations of rheumatology, multiple myeloma, and lung cancer patients, as well as large percentages of African-Americans in these groups. Additionally, this Core facilitates patient enrollment at all 6 distinct hospital sites and affiliated institutions (eg, Grady Memorial Hospital). Core staff will maintain a comprehensive RedCap database on each patient, including metadata and test results, which will be invaluable for later data mining.

抽象的： 拟议的样品采购和临床核心（SPCC；核心 1）旨在提供统一的、 全面、集中的患者样本采集服务（保留临床样本和 前瞻性收集的血液样本）以支持项目 1-3 和核心 2 的研究。SPCC 是一个 从 2020 年 2 月开始启动、优化和扩展的类似（无资金）活动的结果， COVID-19 大流行开始时，SPCC 将协调 IRB 申请、研究参与者招募、 样本采购（包括由医院抽血师实施血液采集，以减少 每个患者的静脉穿刺次数和个人防护装备的使用）、样品处理以及样品分配到项目 1-3 和核心 2. SPCC 活动将由监管专家、临床研究人员（来自风湿病学、 肿瘤学、血液学和传染病）、临床病理学家、护士协调员和经过培训的 该小组的工作将通过 3 个领导层之间的定期会议进行协调。 项目、核心 2 和行政核心 SPCC 活动将实现以下具体目标： 目标 1：扩展我们现有保留的临床样本库，以支持前瞻性血清监测 SPCC 将通过以下方式扩展我们现有的保留样本库。 专门针对本计划感兴趣的患者的样本（例如，系统性红斑狼疮 [SLE]）。由此产生的纵向生物样本库将支持 Core 2 的详细系列血清监测研究。 目标 2：协调所有监管、招募、样品采购、加工、分发和存储 SPCC 调查人员将维持项目 1-3 所需的前瞻性血液采集活动。 IRB 对前瞻性临床样本采集的全面批准 他们将密切合作。 与所有项目的研究人员一起整合样品需求，并制定有效样品的时间表 满足项目 1-3 需求的收集工作人员将协调收集、分配样本研究编号、 等分并标记样品，然后分发给各个项目的研究人员或冷冻储存 直到需要时，样本和患者元数据将被输入到安全的 RedCap 数据库中。 该核心使 U54 调查人员能够充分利用埃默里大学的独特优势，包括大型 风湿病、多发性骨髓瘤和肺癌患者群体，以及很大比例的 此外，该核心还促进了这些群体中的非裔美国人在所有 6 家不同医院的登记。 站点和附属机构（例如格雷迪纪念医院）核心人员将维护全面的 RedCap。 每个患者的数据库，包括元数据和测试结果，这对于以后的数据挖掘非常有价值。