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临床试验/NCT06559319
NCT06559319进行中(未招募)不适用

Evaluation Of the Basophil Activation Test in Child Egg Allergy Diagnosis

Xia Peng1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2024年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
174
试验地点
1
主要终点
Specificity of the BAT

研究概览

简要总结

In this study, basophil activation test (BAT) established by the investigators' lab was evaluated for its sensitivity and specificity in child egg allergy diagnosis. Children with suspected IgE mediated allergy to egg will be recruited in the study. Specific IgE to egg allergen and BAT will be detected. The diagnostic accuracy of the BAT will be assessed against clinical diagnosis based on history, clinical symptoms and laboratory results.

详细描述

In china, the prevalence of food allergy in in preschool children was about 7%. Diagnosis of food allergy is mainly based on a combination of clinical history, clinical manifestations and related supplementary examinations, including skin prick testing (SPT), serum specific IgE testing (sIgE), and oral food challenge (OFC). Although OFC is the gold standard for allergy diagnosis, it is rarely conducted in clinic for the low safety. Until now, serum specific IgE assays against allergen are the most commonly used in vitro diagnostic approach in China. However, specific-IgEs are sensitive, but not specific for diagnosis of food allergy. Moreover, food allergy could not be excluded when sIgE results are negative (<0.35KU/L). Thus, more accurate and safer test is needed. BAT was shown to have good accuracy for food allergy diagnosis. BAT is an ex vivo functional assay that measures by flow cytometry the degree of basophil activation after stimulation with an allergen. However, experimental strategies for BAT reported in the literatures are different. Some research even used 12 kinds of antibodies to identity basophils. In previous study, the investigators established BAT using 4 kinds of antibodies. Basophils could be distinguished well from other cells. In this study, children aged 4 months to 6 years who visit pediatric and emergency department, and are suspected with egg allergy will be included in study. Detailed information about clinical history and manifestations will be collected. Serum sIgE to food and BAT will be detected. The proposed study intends to analyze sensitivity and specificity of the established BAT according to the clinical comprehensive diagnosis results, and evaluate its efficacy to diagnose food allergy in children.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
4 Months 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 1.Patients with hematological tumors, autoimmune diseases, organ transplantation, and immunodeficiency diseases
  • 2.Take immunosuppressants, immunomodulators, statins, and inject anesthetics within 3 weeks

结局指标

主要结局

Specificity of the BAT

时间窗: 2 days

Specificity is defined as the capacity for BAT to have a negative result when comprehensive diagnosis result is also negative.

Sensitivity of the BAT

时间窗: 2 days

Sensitivity of the BAT compare to clinical comprehensive diagnosis with a threshold value of 5% for the BAT in a population of child egg allergy. Sensitivity is defined as the capacity for BAT to have a positive result when comprehensive diagnosis result is also positive

次要结局

未报告次要终点

研究者

发起方
Xia Peng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xia Peng

associate senior technologist

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

研究点 (1)

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