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.

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