SARS-CoV-2 Clinical Cohort Core

临床队列核心总结 一个有效、可靠和全面的临床数据和生物标本来源对 杜兰大学COVID抗体和免疫网络（TUCAIN）的设计和实施。U54 中心临床队列核心将通过汇集目前正在研究的优秀研究者来满足这一需求。 导致整个生命周期中与该提案高度相关的患者队列的多样性。整体 该核心的目标是开发和维护一组由人类受试者从童年开始组成的多样化队列 并纵向收集完成这两项工作所需的临床数据和生物标本。 TUCAIN和SeroNet活动。核心将通过以下方式支持免疫测定核心以及项目1和2 为患者招募、人口统计学和临床数据收集以及系列样本提供集中团队 收集和处理。在这一角色中，核心还将负责维护所有道德审批， 以及维护电子样本日志，并根据需要向项目1和2提供样本和临床数据。 临床队列核心将负责以下具体目标：（1）协调安全和有效的 从入组受试者中采集系列样本。通过集中样本收集和处理， 数据收集，我们将提高该中心所做的所有工作的严谨性和可重复性。(2)利用现有 COVID-19队列。几名TUCAIN研究人员已经建立了COVID-19患者的队列 在急性感染住院期间招募。作为这些研究的一部分收集的样本和临床样本 将提供给TUCAIN和SeroNet。(3)在现有招募的COVID-19幸存者队列的基础上开展工作 从社区中。图凯恩调查人员一直处于应对COVID-19的最前沿，并且取得了良好的成果 已建立的实验室确认或感知感染受试者队列。数据和生物标本 将提供给TUCAIN和SeroNet。(4)利用现有资金支持儿科 哮喘队列进行症状监测。我们将利用作为现有队列的一部分收集的样本 孩子们。通过至少三年的跟踪，我们将能够确定血清学的变化， 响应时间。(5)建立一个大型实体瘤和血液肿瘤患者队列。该队列将 作为了解恶性肿瘤和化疗对血清学的影响的关键资源， 对SARS-CoV-2感染的反应。这些宝贵的资源将使杜兰大学和更广泛的研究人员 科学界对SARS-CoV-2的血清学反应进行了大量研究。成功 这些队列的开发和管理将大大提高研究潜力， 免疫测定核心和项目1和2以及SeroNet的更大目标。

Clinical Cohort Core Summary An efficient, reliable and comprehensive source of clinical data and biological specimens is essential to the design and implementation of the Tulane University COVID Antibody and Immunity Network (TUCAIN). U54 Center. The Clinical Cohort Core will fill this need by bringing together outstanding investigators who are currently leading a diversity of patient cohorts from across the lifespan that are highly relevant to this proposal. The overall goal of this Core is to develop and maintain a diverse set of cohorts made up of human subjects from childhood to the elderly and to longitudinally collect clinical data and biological specimens required to complete both TUCAIN and SeroNet activities. The Core will support the Immunoassay Core as well as both Projects 1 & 2 by providing a centralized team for patient recruitment, demographic and clinical data collection and serial sample collection and processing. In this role, the Core will also be responsible for maintaining all ethics approvals as well as maintaining electronic sample logs and providing samples and clinical data to Projects 1 & 2 as needed. The Clinical Cohort Core will be responsible for the following Specific Aims: (1) Coordinate the safe and efficient collection of serial samples from enrolled subjects. By centralizing sample collection and processing as well as data collection, we will enhance the rigor and reproducibility of all work done by this Center. (2) Leverage existing COVID-19 cohorts. Several TUCAIN investigators have already established cohorts of COVID-19 patients recruited during hospitalization for their acute infection. Samples and clinical collected as part of these studies will be made available to TUCAIN and SeroNet. (3) Build on existing cohorts of COVID-19 survivors recruited from the community. TUCAIN investigators have been at the forefront of the COVID-19 response and have well established cohorts of subjects with laboratory-confirmed or perceived infection. Data and biological samples from these cohorts will be available to TUCAIN and SeroNet. (4) Leverage existing funds supporting a pediatric asthma cohort to perform syndromic surveillance. We will utilize samples collected as part of an existing cohort of children. By following them for at least three years, we will be able to identify changes in the serological response over time. (5) Establish a large cohort of patients with solid and hematologic tumors. This cohort will serve as a critical resource for understanding the impact of malignancies and chemotherapy on the serological response to SARS-CoV-2 infection. These valuable resources will allow investigators at Tulane and the wider scientific community to pursue a multitude of studies on the serological response to SARS-CoV-2. Successful development and management of these cohorts will significantly enhance the research potential of the Immunoassay Core and Projects 1 & 2 as well as the larger goals of SeroNet.