Core 1: Sample Procurement and Clinical Core

核心1：样品采购和临床核心

• 批准号: 10680629
• 负责人: John D Roback
• 金额: $ 22.61万
• 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 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10680629
• 关键词: 2019-nCoV; Address; African American population; Age; Aliquot; Ambulatory Care Facilities; Anemia; Autoimmunity; Blood; Blood specimen; COVID-19; COVID-19 pandemic; COVID-19 patient; 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; 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; SARS-CoV-2 infection; SARS-CoV-2 positive; Sampling; Sampling Studies; Schedule; Secure; Serology; 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; participant enrollment; patient population; programs; prospective; recruit; repository; research clinical testing; sample archive; sample collection; serosurveillance; severe COVID-19

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; Core 1）旨在提供统一的， 用于收集患者样品的全面和集中式服务（保留临床标本和 前瞻性收集的血液样本）支持项目1-3和核心2的研究。SPCC是一个 从2020年2月开始，在 共同19-19大流行的开始。 SPCC将协调IRB应用程序，研究参与者招聘， 样品采购（包括医院的静脉治疗家的手术以减少 每名患者和PPE使用），样本处理以及对项目1-3和核心的样品分布 2。SPCC活动将由监管专家，临床研究人员进行（来自风湿病学， 肿瘤学，血液学和传染病），临床病理学家，护士协调员和训练有素 技术人员。该小组的努力将通过3号领导之间的常规会议进行协调 项目核心2和行政核心。 SPCC活动将实现以下特定目标： 目的1：扩展我们现有的保留临床样本存储库，以支持预期的Serasurveellance 该计划的目标人群。 SPCC将通过 特别针对感兴趣的患者的样本到该计划（例如，全身性红斑狼疮 [SLE]）。由此产生的纵向生物座席将支持核心2的详细串行式Serasurboothance研究。 目标2：协调所有监管，招聘，样品采购，处理，分发和存储 项目1-3所需的前瞻性血液收集活动。 SPCC调查人员将维持 综合IRB批准，用于预期收集临床样本。他们将密切合作 来自所有项目的调查人员以巩固样本需求，并制定一个有效样本的时间表 收集以满足项目1-3的需求。员工将协调收集，分配样本研究编号， 等分试样和标签样品，然后分配给各个项目的调查人员，或者存储冻结 直到需要。样品和患者元数据将输入安全的RedCap数据库。 该核心使U54调查人员能够在埃默里（Emory）中获得最佳优势，包括大型 风湿病学，多发性骨髓瘤和肺癌患者的种群以及很大一部分 这些群体中的非裔美国人。此外，该核心有助于所有6个不同医院的患者入学 地点和会员机构（例如Grady Memorial Hospital）。核心人员将保持全面的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宝贵。