A prospective registry, biobank and observational study of food allergy

食物过敏的前瞻性登记、生物库和观察研究

• 批准号: 10581632
• 负责人: Corinne Keet
• 金额: $ 517.92万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-03-01 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10581632
• 关键词: Adolescent; Affect; Age; Allergic; Allergic Reaction; Allergy to eggs; Allergy to peanuts; American; Asthma; Basophils; Caring; Characteristics; Clinical; Clinical Treatment; Clinical Trials; Complication; Data; Disease; Education; Emergency department visit; Enrollment; Food; Food Hypersensitivity; Frequencies; Fright; Funding; Funding Opportunities; Future; Genetic; Goals; Health Technology; Heterogeneity; Hypersensitivity; IgE; Immunologics; Individual; Infrastructure; Intervention; Investigation; Knowledge; Lead; Leadership; Life; Mediating; Medical; Methods; Milk; Milk Hypersensitivity; Mobile Health Application; Monitor; Observational Study; Patient Recruitments; Patients; Phenotype; Population; Prevention; Reaction; Registries; Research; Resources; Risk; Risk Marker; Risk Reduction; Sampling; Severities; Shapes; biobank; biomarker identification; clinical care; clinical investigation; clinically relevant; cohort; comorbidity; design; egg; experience; food allergen; innovation; mHealth; method development; novel; participant enrollment; personalized medicine; phenotypic biomarker; predictive marker; prospective; reaction rate; recruit; repository; risk prediction; risk/benefit ratio; specific biomarkers; treatment response

Project Summary Food allergy is a common disease that affects up to 15 million Americans. Although clinically there appears to be a wide spectrum of disease, sub-types of food allergy with different clinical courses, co-morbidities and responses to therapy have not been systematically identified. Identifying such sub-types of food allergy will allow for tailored care of food allergic individuals. A second major research gap is our understanding of the absolute risk and predictors of serious allergic reactions among those with food allergy who are receiving high quality medical care. Establishing the risk and predictors of serious reactions will have critical implications for determining the risk:benefit ratio for food allergy treatments, educating patients, identifying targets for reducing risk, and determining the best candidates for treatment. This proposal is create a large repository, biobank and prospective observational study of food allergic patients by enrolling 2000 subjects with IgE mediated milk, egg or peanut allergy. Sub-types of food allergy will be identified using unsupervised methods based on comprehensive clinical and immunologic data. The rate of reactions to foods will be closely monitored using innovative mobile health technology. In addition to those major goals, the infrastructure created in this observational cohort through the formation of a registry of well phenotyped food allergic patients and the development of methods to monitor reactions will enable subsequent clinical trials funded by CoFAR to recruit and proceed efficiently, and will provide samples for the opportunity fund. The specific aims of this project are: (1) To establish a large registry and biobank of subjects with milk, egg and/or peanut allergy, (2) To establish phenotypes of food allergy by clinically and immunologically characterizing food allergic individuals (Aim 2A) and to identify predictors of these phenotypes (Aim 2B), and (3) To establish the rate of food allergic reactions among individuals with food allergy (Aim 3A) and determine predictors of reaction frequency and severity (Aim 3B). The results of these investigations will help inform clinical care of food allergic individuals by allowing for tailored care of food allergic individuals, and by informing the risk:benefit ratio for food allergy treatments. This project will also critically advance research into food allergy by providing a registry from which to recruit patients for CoFAR, data on phenotypes which can be used to shape future clinical investigations, and data on predictors of reaction rates which can be used to design novel interventions.

项目摘要 食物过敏是一种常见疾病，影响多达1500万美国人。尽管临床上似乎 是一种广泛的疾病，具有不同临床病程的食物过敏亚型，合并症和 对治疗的反应尚未系统地确定。识别这些食物过敏的亚型将 允许对食物过敏的个体进行定制护理。第二个主要的研究差距是我们对 食物过敏者中严重过敏反应的绝对风险和预测因素， 优质医疗服务。确定严重反应的风险和预测因素将对以下方面产生重要影响： 确定食物过敏治疗的风险：效益比，教育患者，确定减少食物过敏的目标， 风险，并确定治疗的最佳候选人。这个建议是建立一个大型的储存库，生物库， 2000例食物过敏患者IgE介导的牛奶、鸡蛋过敏的前瞻性观察研究 或者花生过敏食物过敏的亚型将使用基于以下内容的无监督方法进行识别： 全面的临床和免疫学数据。对食物的反应率将被密切监测， 创新的移动的医疗技术。除了这些主要目标之外， 通过形成良好表型食物过敏患者的登记表和观察队列， 开发监测反应的方法将使CoFAR资助的后续临床试验能够招募 并将为机会基金提供样本。该项目的具体目标是： (1)建立牛奶、鸡蛋和/或花生过敏受试者的大型登记和生物库，（2）建立 通过临床和免疫学表征食物过敏个体来确定食物过敏表型（Aim 2A） 并确定这些表型的预测因子（目的2B）;（3）确定食物过敏反应的发生率 在食物过敏个体中（Aim 3A），并确定反应频率和严重程度的预测因子（Aim 3B）。这些调查的结果将有助于通过允许食物过敏个体的临床护理， 食物过敏患者的量身定制护理，并告知食物过敏治疗的风险：收益比。这 该项目还将通过提供一个登记处来招募新的研究人员， 用于CoFAR的患者，可用于塑造未来临床研究的表型数据，以及 反应率的预测因子，可用于设计新的干预措施。