Clinical Core: Exacerbation-Prone Pediatric Asthmatics and Control Populations

临床核心：易加重的儿童哮喘和对照人群

基本信息

批准号：
10009469
负责人：
ANDREW H LIU
金额：
$ 28.31万
依托单位：
NATIONAL JEWISH HEALTH
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-09-01 至 2022-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10009469
关键词：
Advertisements Asthma Bioinformatics Biologic Characteristic Biometry Blood Bronchodilator Agents CD4 Positive T Lymphocytes Child Childhood Childhood Asthma Classification Clinic Visits Clinical Clinical Research Protocols Clinics and Hospitals Collection Colorado Computerized Medical Record Control Groups Data Databases Development Economic Burden Emergency department visit Enrollment Ethics Exclusion Criteria Exhalation Grant Guidelines Home visitation Hospitalization Human Human Resources Human Subject Research Hypersensitivity Hypersensitivity skin testing IgE Immune response Infection prevention Institutional Review Boards Longitudinal Studies Longitudinal prospective study Lung Methods Monitor Mucous body substance Nasal Epithelium Nitric Oxide Nose Participant Patient Recruitments Patients Phenotype Physiology Population Control Preparation Procedures Process Protocols documentation Questionnaires Recording of previous events Regulation Research Research Activity Research Personnel Resistance Resources Rhinitis Rhinovirus Risk Route Sampling Seasonal Variations Severities Spirometry Sputum Standardization Study Subject System Techniques Testing United States National Institutes of Health Urine Virus asthma exacerbation asthmatic atopy base cost data de-identification electronic data eosinophil experience follow-up inclusion criteria indexing inflammatory marker minimally invasive molecular phenotype neutrophil novel strategies participant retention phenotypic data recruit respiratory respiratory virus response skin hypersensitivity surfactant transcriptome sequencing urban children viral detection

项目摘要

The Clinical Core will implement and manage the human subjects research for the PPG Projects. Centralizing the human subjects research activities for all projects of the Center will save effort and cost by consolidating the necessary personnel, facilities, and resources. The Clinical Core investigator and personnel have a successful track record with similar multi-project clinical research protocols for over a decade. The Clinical Core approach has been validated by preliminary studies with the investigators in this proposal. Aim 1: Recruit, enroll, and retain study subjects. The clinical research protocol will consist of a longitudinal, prospective study of exacerbation-prone asthmatic children (n=100) and cross- sectional biosampling of three control groups: 1) mild, exacerbation-resistant asthmatic children (n=100); 2) non-asthmatic, atopic children (n=50); and 3) non-asthmatic, non-atopic children (n=50). These control groups will be used to characterize the spectrum of airway, CD4+ T cell, and surfactant responses that are not involved in exacerbations. Participants will be identified for recruitment through IRB-approved means using recruitment databases, electronic medical records, and public, clinic, and hospital advertisements. Potential participants will be screened with a questionnaire that collects contact information and inclusion and exclusion criteria. Regarding longitudinal follow-up of the exacerbation-prone group, the Clinical Core team has a strong history of enrollment, recruitment, and >90% participant retention in longitudinal studies of urban children with asthma. Aim 2: Perform clinical characterization of participants through asthma and atopy phenotyping and biosampling of study subjects. Phenotyping will include a determination of asthma, atopic status, exacerbations, and asthma severity. Biosamples will include induced sputum, nasal brush, nasal mucus, blood, and urine. Aim 3: Provide data and sample management. The Clinical Core will provide biosample tracking, routing, preparation and testing, and will provide de-identified data to the Projects and the Biostatistics, Bioinformatics and Environmental Sampling Core. Phenotyping data will be entered into a HIPPA-compliant, IRB-approved REDCap (Research Electronic Data Capture) database (NIH/NCATS Colorado CTSI Grant Number UL1 TR001082).

临床核心将为 PPG 实施和管理人体受试者研究项目。集中中心所有项目的人类受试者研究活动将通过整合必要的人员、设施和资源来节省精力和成本。这临床核心研究者和人员在类似的多项目方面拥有成功的记录十多年来的临床研究方案。临床核心方法已得到验证与本提案中的研究人员进行初步研究。目标 1：招募、注册和保留研究对象。临床研究方案将包括对有哮喘发作倾向的儿童 (n=100) 进行的一项纵向、前瞻性研究和交叉研究对三个对照组进行分段生物采样：1）轻度、难治性哮喘儿童 (n=100)； 2）非哮喘、特应性儿童（n=50）； 3) 无哮喘、无特应性的儿童（n=50）。这些对照组将用于表征气道、CD4+ T 细胞、和不参与恶化的表面活性剂反应。将通过 IRB 批准的方式确定招募参与者招聘数据库、电子病历以及公共、诊所和医院广告。潜在的参与者将通过收集联系方式的调查问卷进行筛选信息以及纳入和排除标准。关于纵向随访临床核心团队拥有丰富的入组、招募、在城市哮喘儿童的纵向研究中，>90% 的参与者保留率。目标 2：通过哮喘和过敏症对参与者进行临床表征研究对象的表型分析和生物采样。表型分析将包括确定哮喘、特应性状态、恶化和哮喘严重程度。生物样品将包括诱导痰、鼻刷、鼻粘液、血液和尿液。目标 3：提供数据和样本管理。临床核心将提供生物样本跟踪、路由、准备和测试，并将向项目和项目提供去识别化的数据生物统计学、生物信息学和环境采样核心。表型数据将是符合 HIPPA 标准、IRB 批准的 REDCap（研究电子数据采集）数据库（NIH/NCATS 科罗拉多州 CTSI 授权号 UL1 TR001082）。