Clinical Core

临床核心

基本信息

批准号：
10598119
负责人：
Jane Hoyt Buckner
金额：
$ 103.61万
依托单位：
BENAROYA RESEARCH INST AT VIRGINIA MASON
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-03-29 至 2027-02-28
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10598119
关键词：
Acute Adult Allergic Asthma Autoimmune Diseases Bioinformatics Biological Child Childhood Asthma Clinic Visits Clinical Clinical Data Clinical Protocols Clinical Research Consent Forms Data Analyses Data Collection Data Set Databases Ensure Family history of Genomics Home Human Subject Research Immunology Infrastructure Inpatients Institutional Review Boards Intervention Laboratories Link Longitudinal cohort Patient Recruitments Pediatric cohort Phenotype Policies Protocols documentation Recording of previous events Registries Research Research Institute Research Personnel Research Project Grants Rheumatoid Arthritis Role Sampling Scientist Specimen Sputum System Translational Research United States National Institutes of Health Viral Respiratory Tract Infection Virginia Vulnerable Populations cohort data management human subject protection nasal swab patient responsibilities peripheral blood programs recruit repository urban setting

项目摘要

SUMMARY/ABSTRACT The Clinical Core will be responsible for patient recruitment, sample acquisition, clinical data collection, and regulatory compliance for both of the research projects in the HIPC Center entitled “Systems immunology profiling of respiratory viral infections in vulnerable populations”. The Clinical Core has three Specific Aims. In Specific Aim 1, the Clinical Core will identify, recruit, and follow a pediatric cohort with asthma and an adult cohort with rheumatoid arthritis before and after acute respiratory viral infection. In Specific Aim 2, the Clinical Core will manage the acquisition, processing, and distribution of biologic specimens with associated clinical information. In Specific Aim 3, the Clinical Core will ensure regulatory compliance and the protection of human subjects. To accomplish these aims, the Clinical Core will leverage the existing infrastructure of the Childhood Asthma in Urban Settings (CAUSE) Network and the Benaroya Research Institute at Virginia Mason (BRI). For Research Project 1, the Clinical Core will recruit children with asthma, children with allergic sensitization, and healthy children with no personal history of asthma or allergic sensitizations. For Research Project 2, the Clinical Core will recruit adults with rheumatoid arthritis and healthy adults with no personal or family history of autoimmune disease. The Clinical Core will also be responsible for longitudinal sampling of peripheral blood, nasal swabs, and sputum collected at four in-patient clinic visits: baseline, during acute respiratory viral infection (ARVI; 4-6 days post start of ARVI), 4 weeks post ARVI, and 12 months post baseline. Nasal swabs will also be collected at home at the start and end of ARVI. The Clinical Core will also collect demographic and clinical data using the HIPC clinical characterization template. Samples and linked clinical data will be tracked in the BRI Sample Repository database where datasets can easily be queried for sample selection and provided to research scientists for samples upon unblinding, or to the Data Management & Analysis Core for bioinformatics analysis. The Clinical Core will also be responsible for sample processing as well as sample distribution to each of the Research Projects, the Genomics Core, and the Adaptive Phenotyping Core. The Clinical Core will ensure regulatory compliance and the protection of human subjects by developing and managing registry and study documents including clinical protocols, IRB applications, and informed consent forms. Thus, the Clinical Core has an essential role in ensuring the HIPC Center achieves its scientific objectives.

摘要/摘要临床核心将负责患者招募、样本采集、临床数据收集和重债穷国中心题为“系统免疫学”的两个研究项目的监管合规性脆弱人群呼吸道病毒感染概况”。临床核心有三个具体目标。具体目标 1，临床核心将识别、招募和跟踪患有哮喘的儿科队列和成人在特定目标 2 中，急性呼吸道病毒感染前后的类风湿性关节炎队列。核心将管理生物样本的采集、处理和分配以及相关的临床在具体目标 3 中，临床核心将确保法规遵从性和对人类的保护。为了实现这些目标，临床核心将利用童年的现有基础设施。城市环境中的哮喘 (CAUSE) 网络和弗吉尼亚梅森贝纳罗亚研究所 (BRI)。研究项目1，临床核心将招募哮喘儿童、过敏儿童和没有哮喘或过敏史的健康儿童对于研究项目 2，临床核心将招募患有类风湿性关节炎的成年人和没有个人或家族史的健康成年人自身免疫性疾病的临床核心还将负责外周血的纵向采样，在四次住院就诊时收集的鼻拭子和痰液：基线、急性呼吸道病毒期间感染（ARVI；ARVI 开始后 4-6 天）、ARVI 后 4 周以及基线后 12 个月。也将在 ARVI 开始和结束时在家中收集。临床核心还将收集人口统计数据和数据。将使用 HIPC 临床特征模板跟踪临床数据和链接的临床数据。在 BRI 样本存储库数据库中，可以轻松查询数据集以进行样本选择和提供给研究科学家以获取揭盲后的样本，或提供给数据管理和分析核心以获取临床核心还将负责样本处理和样本分析。分配给每个研究项目、基因组核心和自适应表型核心。临床核心将通过开发和保护人类受试者来确保法规遵从性和保护管理注册和研究文件，包括临床方案、IRB 申请和知情同意书因此，临床核心在确保重债穷国中心实现其科学性方面发挥着至关重要的作用。目标。