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临床试验/NCT02194530
NCT02194530已完成不适用

Pilot Study to Collect Blood From Research Subjects Allergic and Non-allergic to Peanut to Study Immune Modulation With Anti-IgE Therapy in Mice

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2015年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
1
主要终点
Blood test to determine peanut allergy and peanut specific IgE and IgG

研究概览

简要总结

This pilot study is will examine the pathways involved in allergic response, primarily in food allergy; specifically peanut allergy. We will also study non-allergic donors as well as patients with atopic disorders, primarily as control subjects. We believe that this study will lead to discovery of significant pathways involved in the allergic pathway that can be explored in more detail during follow-up studies in order to address mechanistic questions that cannot be answered in a pilot trial. We believe that such a pilot study represents the ideal approach to identify effective therapeutic interventions and to simultaneously better understand the underlying mechanistic properties involved in the allergy cascade. We think that this study forms the basis for a novel avenue of research into the pathogenesis of allergic pathways, a disease that is still associated with significant morbidity and mortality.

详细描述

The study aims to characterize the pathways involved in the allergic response, primarily in food allergy; specifically peanut allergy. We will also study non-allergic donors as well as patients with atopic disorders, primarily as control subjects. All eligible study participants will have documented elevated total IgE levels, peanut positivity or another antigen/allergen specific elevated IgE (ie common indoor/outdoor allergens) prior to being enrolled in the study. Our study will focus on allergic as well as non-allergic individuals. We plan on collecting samples from a total of 60 patients during one time point (peanut allergic individuals, non-atopic/allergic individuals, atopic individuals-other than peanut allergy). We believe that such a pilot study represents the ideal approach to identify effective therapeutic interventions and to simultaneously better understand the underlying mechanistic properties involved in the allergy cascade. We plan to obtain a detailed history prior to enrollment as well as objective data (ie SPT as well as Immunocap testing results). There will be 3 study groups and studies will be performed on approximately 20 peanut allergic patients, 20 non-allergic controls, and 20 allergic/atopic (non-peanut allergic, but allergic to indoor/outdoor allergen) individuals. There will be one blood draw required at each visit (weeks 0, 4, 8). Each blood draw will require 105 ml of whole blood to be collected in ten heparinized 10-mL tubes and one EDTA tube. We plan to assess the levels of total IgE and IgG as well as antigen specific IgG and IgE in the peripheral blood of patients. We will specifically perform ELISA testing that detects these levels. We will also perform in vitro CD4+ T cell proliferation assays. For this purpose, patients' peripheral T cells will be isolated with a combination of magnetic beads and flow cytometric sorting.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Blood test to determine peanut allergy and peanut specific IgE and IgG

时间窗: 1 year

There will be one blood draw at each visit (weeks 0, 4, 8). Each blood draw will require 105 mL of whole blood to be collected in ten heparinized 10 mL tubes and one EDTA tube. We plan to assess the levels of total IgE and IgG as well as antigen specific IgG and IgE in the peripheral blood of patients. We will specifically perform ELISA testing that detects these levels. We will also perform in vitro CD4+ T cell proliferation assays.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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