DATA COORDINATING CENTER TO PROVIDE SERVICES TO WORK COLLABORATIVELY WITH THE NATIONAL NEUROHIV TISSUE CONSORTIUM CLINICAL SITES TO PROVIDE MANAGEMENT AND DATABASE CAPABILITIES, SCIENTIFIC EXPERTISE,

数据协调中心提供服务，与国家神经艾滋病毒组织联盟临床站点合作，提供管理和数据库能力、科学专业知识、

• 批准号: 10923530
• 负责人: Seth Sherman
• 金额: $ 305.42万
• 依托单位: THE EMMES COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-07 至 2024-08-06
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10923530
• 关键词: Address; Adherence; Aging; Autopsy; Bioinformatics; Biological Markers; Biometry; Blood; Brain; Catalogs; Central Nervous System; Central Nervous System Diseases; Cerebrospinal Fluid; Clinical; Clinical Data; Communities; Contracts; Data; Data Collection; Data Coordinating Center; Databases; Disease; Disease Outcome; Ensure; Epidemiology; Evaluation; Funding; Genetic; HIV; HIV Seronegativity; HIV Seropositivity; HIV-1; Heart; Kidney; Knowledge; Laboratories; Liquid substance; Liver; Lung; Monitor; National Institute of Drug Abuse; National Institute of Mental Health; National Institute of Neurological Disorders and Stroke; Neuropsychological Tests; Organ; Outcome; Pathologic; Patients; Peripheral; Peripheral Nervous System; Protocols documentation; Research; Research Domain Criteria; Research Personnel; Research Project Grants; Resource Sharing; Sampling; Services; Signal Pathway; Site; Specimen; Spinal Cord; Testing; Therapeutic; Tissues; Toxicology; Update; Viral; Viral reservoir; Work; central database; clinical research site; cohort; comorbidity; data management; data repository; neuroAIDS; neurobehavioral; neuroimaging; novel; operation; pre-clinical; public health relevance; sample collection; sound

The National NeuroHIV Tissue Consortium (NNTC), currently funded by NIMH, NINDS, NIDA, and NIA, was originally established in 1998 to collect, store, and distribute samples of central and peripheral nervous system tissue, cerebrospinal fluid, blood, and other organs such as heart, lung, liver, and kidney collected from HIV positive and negative patients, to support researchers around the world who wish to pursue sound research projects and further our knowledge of neuroHIV disorders. In addition to brain banking operations, the clinical sites follow and collect ante-mortem data from an active cohort of HIV positive patients including an extensive neurobehavioral battery including neuropsychological testing and psychiatric assessments, neuromedical evaluation, laboratory results, and fluid sample collection for toxicology and sample banking. The new site contract will include revisions to the existing data collection protocol adding new RDoC assessments, neuroimaging, biomarker testing, and updates to various neurobehavioral battery. Detailed pathological evaluations of brain, spinal cord, and peripheral organs are conducted post-mortem and samples are then banked according to strict established protocols to ensure uniformity across the four clinical sites. The DCC for the NNTC under the current contract is tasked with serving as the central data repository, monitoring site adherence to study protocols and SOPs and providing data management, biostatistical and bioinformatic support to enable the clinical sites to effectively catalogue and maintain specimens and clinical data while also facilitating the sharing of resources with the broader scientific community.

国家神经HIV组织联盟(NNTC)目前由NIMH、NINDS、NIDA和NIA资助，最初成立于1998年，目的是收集、存储和分发从HIV阳性和阴性患者身上收集的中枢和周围神经系统组织、脑脊液、血液和其他器官(如心、肺、肝和肾)的样本，以支持世界各地希望从事合理研究项目的研究人员，并加深我们对神经HIV疾病的了解。除了脑库业务，临床站点还跟踪和收集艾滋病毒阳性患者活跃队列的死亡前数据，包括广泛的神经行为组合，包括神经心理测试和精神评估、神经医学评估、实验室结果，以及毒理学和样本库的液体样本收集。新的现场合同将包括对现有数据收集协议的修订，增加新的RDoC评估、神经成像、生物标记物测试，以及对各种神经行为电池的更新。在死后对大脑、脊髓和周围器官进行详细的病理评估，然后根据严格的既定方案保存样本，以确保四个临床部位的一致性。根据目前的合同，NNTC的DCC的任务是充当中央数据存储库，监测站点对研究方案和SOP的遵守情况，并提供数据管理、生物统计和生物信息学支持，使临床站点能够有效地对标本和临床数据进行编目和维护，同时还促进与更广泛的科学界共享资源。