PREVENTABLE Biorepository and Laboratory

可预防的生物样本库和实验室

• 批准号: 10259720
• 负责人: Laura Kristin NEWBY
• 金额: $ 86.62万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10259720
• 关键词: Adverse effects; Aging; All of Us Research Program; Alzheimer' s Disease; Ancillary Study; Biological; Biological Markers; Biological Specimen Banks; Cardiovascular Diseases; Child Health; Clinic; Clinical; Cognitive; Collection; Communication; Communities; Coronary heart disease; Dementia; Development; Disease; Disease Progression; Elderly; Ensure; Evaluation; Event; Funding; Future; Geroscience; Goals; Health; Impaired cognition; Impairment; Infrastructure; International; Laboratories; Leadership; Libraries; Lipids; Logistics; Longevity; Molecular; Outcome; Participant; Patients; Persons; Physical Function; Physiological; Policies; Polypharmacy; Positioning Attribute; Procedures; Process; Protocols documentation; Quality Control; Randomized; Randomized Clinical Trials; Registries; Research; Research Personnel; Resources; Retrieval; Risk; Role; Sampling; Science; Specific qualifier value; Subgroup; Testing; Treatment Efficacy; United States National Institutes of Health; biobank; cardiovascular health; cardiovascular risk factor; cohort; design; disability; experience; follow-up; frailty; healthy aging; individualized medicine; inflammatory marker; insight; medication compliance; mild cognitive impairment; multiple chronic conditions; operation; precision medicine; prevent; programs; protocol development; randomized trial; treatment effect; working group

The Biorepository Core will manage collection, processing and storage of biospecimens from 17,000 PREVENTABLE participants using state-of-the-art biobanking operations in the Mayo Clinic Biorepository. Biospecimens provide a number of important operational and scientific opportunities to determine the role of a moderate-intensity statin in preventing dementia (including Alzheimer’s disease) and prolonging disability-free survival in patients 75 years and older without clinically evident coronary heart disease, including those with frailty, impaired physical function, mild cognitive impairment, polypharmacy, and multi-morbidity. These include confirming treatment efficacy and/or participant compliance with therapy (e.g., expected levels of lipid lowering with statins) and defining subgroups that preferentially benefit, furthering the construct of precision medicine. The collection of biospecimens is also an opportunity for discovery science that may provide insights into disease mechanisms, identify new treatment targets, elucidate mechanistic intersections between diseases (e.g., cardiovascular disease [CVD] and dementia). The Biorepository Core will be under the leadership of Drs. Mine Cicek at Mayo and L. Kristin Newby at DCRI. The Mayo Clinic manages hundreds of active biorepositories, is the central biorepository for the NIH All of Us Research Program, and is uniquely positioned to function as the PREVENTABLE Biorepository. We will assemble a team of experts in aging, geroscience, dementia (including Alzheimer’s disease), frailty, and CVD biomarkers to support proposal development for studies using banked biospecimens as well. The Biorepository team will leverage collective experience to coordinate the collection, processing, storage, retrieval for use in ancillary studies, and eventual transfer of the biospecimen library to BioLINCC. AIM 1. Collect, process, transfer, and store 17,000 baseline samples in randomized participants, implement biorepository policies and procedures, maintain effective communications with trial leadership, facilitate transfer of biospecimens to BioLINCC at study close, and apply continuous quality control to ensure the integrity of the biospecimens for future studies. AIM 2. Support protocol-specified laboratory testing. Study drug adherence and physiologic effect will be assessed by changes in lipid levels. AIM 3. Collaborate in planning future biomarker studies to identify important markers of cardiovascular risk, cognitive decline, healthy aging, and frailty.

生物库核心将使用梅奥诊所生物库中最先进的生物库操作，管理来自17,000名可预防参与者的生物样本的收集、处理和储存。生物谱学提供了许多重要的操作和科学机会，以确定中等强度的他汀类药物在预防痴呆(包括阿尔茨海默病)和延长75岁及以上没有临床明显冠心病的患者(包括虚弱、身体功能受损、轻度认知障碍、多药联用和多种疾病)患者中的作用。这些措施包括确认治疗效果和/或参与者对治疗的依从性(例如，他汀类药物的预期降脂水平)，以及确定优先受益的亚组，进一步构建精确医学。收集生物标本也是发现科学的机会，可以提供对疾病机制的见解，确定新的治疗目标，阐明疾病(例如心血管疾病[心血管疾病]和痴呆症)之间的机制交叉。生物库核心将由梅奥的Mine Cicek博士和DCRI的L.Kristin Newby领导。梅奥诊所管理着数百个活跃的生物库，是美国国立卫生研究院所有人研究计划的中央生物库，具有作为可预防生物库的独特地位。我们将召集一个由老龄化、老年科学、痴呆症(包括阿尔茨海默病)、虚弱和心血管疾病生物标志物方面的专家组成的团队，以支持也使用银行生物显微镜的研究的提案开发。生物库团队将利用集体经验协调收集、处理、存储、检索以用于辅助研究，并最终将生物谱库转移到BioLINCC。目的1.在随机受试者中收集、处理、转移和存储17,000个基线样本，执行生物信息库政策和程序，与试验领导保持有效沟通，促进在研究结束时将生物样本转移到BioLINCC，并应用持续质量控制，以确保生物样本的完整性，用于未来的研究。目标2.支持特定方案的实验室测试。研究药物依从性和生理效应将通过血脂水平的变化来评估。目的3.合作规划未来的生物标记物研究，以确定心血管风险、认知衰退、健康衰老和虚弱的重要标记物。