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.

摘要： 拟定的样本采购和临床核心（SPCC;核心1）旨在提供统一的， 全面、集中的患者样本采集服务（包括保留的临床样本和 前瞻性采集血样），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、优化和扩大的类似（未资助）活动的结果， COVID-19大流行的开始。SPCC将协调IRB申请、研究受试者招募， 样本采集（包括由医院采血师进行采血， 每个患者的静脉穿刺次数和PPE使用）、样本处理和样本分发至项目1-3和核心 2. SPCC活动将由监管专家、临床研究者（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， 专业人该小组的努力将通过3个国家的领导人定期举行会议加以协调。 项目、核心2和行政核心。SPCC活动将实现以下具体目标： 目的1：扩大我们现有的保留临床样本库，以支持前瞻性血清监测， 该计划的目标人群。SPCC将通过以下方式扩展我们现有的保留样本库： 专门针对本项目感兴趣患者的样本（例如，系统性红斑狼疮 [SLE]）。由此产生的纵向生物库将支持核心2的详细系列血清监测研究。 目标2：协调所有监管、招聘、样本采购、加工、分销和存储 项目1-3所需的前瞻性采血活动。SPCC调查人员将保持 IRB对前瞻性临床样本采集的全面批准。他们将密切合作 与所有项目的调查人员一起，整合样本需求，并制定有效样本采集时间表 以满足项目1-3的需求。工作人员将协调收集，分配样本研究编号， 将样品等分并贴上标签，然后分发给各个项目的研究人员或冷冻储存 直到需要。样本和患者元数据将输入安全的RedCap数据库。 该核心使U 54调查人员能够最大限度地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人群，以及大比例的 这些群体中的非洲裔美国人。此外，该核心有助于所有6家不同医院的患者入组 研究中心和附属机构（如格雷迪纪念医院）。核心员工将维护全面的RedCap 每个病人的数据库，包括元数据和测试结果，这将是非常宝贵的，为以后的数据挖掘。