Precision Medicine Initiative Cohort Program Biobank

精准医学计划队列计划生物样本库

• 批准号: 9378793
• 负责人: Mine Cicek
• 金额: $ 5424.03万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-06-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9378793
• 关键词: Address; Advanced Malignant Neoplasm; Automation; Back; Biological; Blood; Businesses; Characteristics; Client; Clinic; Clinical Research; Clinical Services; Collection; Committee Members; Complex; Data; Disaster Planning; Disease; Elements; Enrollment; Ensure; Environment; Feces; Fee-for-Service Plans; Genome; Genomics; Goals; Health; Healthcare Systems; Hospitals; Human Volunteers; Individual; Information Management; Infrastructure; Institution; Intention; International; Label; Laboratories; Laboratory Research; Life Style; Link; Logistics; Management Information Systems; Medical; Medical Records; PMI cohort; Participant; Patient Care; Patients; Population; Precision Medicine Initiative; Prevention strategy; Process; Protocols documentation; Public Health; Questionnaires; Recovery; Regulation; Research; Research Personnel; Resources; Retrieval; Robotics; Route; Saliva; Sampling; Scientific Advances and Accomplishments; Secure; Services; Ships; Site; Specimen; Specimen Handling; System; Technology; Tissues; Transportation; United States; Urine; Work; arm; biobank; cohort; cost; cost effective; epigenomics; genetic disorder diagnosis; health management; improved; individualized medicine; metabolomics; microbiome; multidisciplinary; precision medicine; programs; quality assurance; recruit; response; scale up; square foot; success; transcriptomics; treatment strategy; virtual; volunteer

PROJECT SUMMARY / ABSTRACT In his State of the Union address on January 20, 2015, President Obama announced his intention to launch the Precision Medicine Initiative (PMI). The goal of the PMI Cohort Program is to enroll one million volunteers into a national cohort that broadly reflects the diversity of the U.S. population and accelerate progress toward a new era of precision medicine on a larger scale than previously possible. The objective of this proposal is to utilize the full resources available through the Mayo Clinic Biorepositories Program and Mayo Medical Laboratories to efficiently and cost effectively support the activities of the PMI Cohort Program with respect to the Biobank, namely, biospecimen collection, kit assembly, biospecimen accessioning, tracking, processing, quality assurance, storage, and distribution. Mayo Medical Laboratories, the third largest reference laboratory in the United States, will enable efficient specimen transportation, routing, and information management between PMI collection sites and the Mayo Clinic Biobank. The aims of this proposal are to: (1) To provide collection kits and leverage existing sample shipment logistics to ensure specimens arrive at Mayo Clinic Rochester in the most expedient, efficient, and safe manner possible, in accordance with all federal and state regulations; (2) Scale up existing state-of-the-art laboratory automation and robotics to process, label, and store biospecimens, using established protocols compliant with laboratory best practices for all steps of specimen handling; (3) Use our high-quality, robust, and secure research laboratory information management system (RLIMS) for detailed tracking of sample receipt, processing, storage, retrieval, and distribution, while protecting participant confidentiality; (4) Apply our comprehensive Quality Management Program to ensure all work carried out is of the highest quality, and safeguard the collection with robust back-up systems and plans for disaster recovery; and (5) Work closely with the Coordinating Center, Collection Sites, and all other PMI Cohort Program Steering Committee Members to share biobanking expertise, infrastructure, and data to further the goals of the PMI. Overall, the Mayo Clinic Biorepositories Program laboratories combined with Mayo Medical Laboratories provide an unparalleled ability to collect, accession, process, distribute, store, and manage virtually any type of biospecimen on behalf of the Precision Medicine Initiative Cohort Program.

项目概要/摘要 奥巴马总统在 2015 年 1 月 20 日的国情咨文中宣布，他打算 启动精准医学计划（PMI）。 PMI 队列计划的目标是招收 100 万人 将志愿者纳入广泛反映美国人口多样性的全国队列中，并加速 迈向比以前更大规模的精准医学新时代。的目标 该提案旨在利用梅奥诊所生物样本库计划提供的全部资源，并且 梅奥医学实验室将高效、经济高效地支持 PMI 队列计划的活动 关于生物样本库，即生物样本采集、试剂盒组装、生物样本加入、跟踪、 加工、质量保证、储存和分销。梅奥医学实验室，第三大参考 美国实验室，将实现高效的样本运输、路线和信息 PMI 收集点和 Mayo Clinic 生物库之间的管理。本提案的目的是：(1) 提供采集套件并利用现有的样本运输物流确保样本到达梅奥 罗切斯特诊所按照所有联邦和法律规定，以最便捷、最有效和最安全的方式 国家法规； (2) 扩大现有最先进的实验室自动化和机器人技术的处理、标签、 并存储生物样本，使用符合实验室最佳实践的既定协议来完成所有步骤 标本处理； (3) 使用我们高质量、稳健、安全的研究实验室信息管理 系统 (RLIMS)，用于详细跟踪样品接收、处理、存储、检索和分发，同时 保护参与者的机密； (4) 应用我们全面的质量管理计划，以确保所有 所开展的工作具有最高质量，并通过强大的备份系统和计划来保护藏品 用于灾难恢复； (5) 与协调中心、收集点和所有其他 PMI 密切合作 群组计划指导委员会成员将分享生物样本库专业知识、基础设施和数据 进一步实现 PMI 的目标。总体而言，梅奥诊所生物样本库计划实验室结合 梅奥医学实验室提供无与伦比的收集、加入、处理、分发、存储和 代表精准医学倡议队列计划管理几乎任何类型的生物样本。