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临床试验/NCT02503800
NCT02503800已完成不适用

The Significance of Blood-tryptase Levels and c-Kit Mutation in the Evaluation of Prognosis and Adverse Reactions in Subjects Undergoing Venom Immunotherapy for Insect Allergy

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
159
试验地点
1
主要终点
The association between tryptase values/c-Kit mutation and immunotherapy adverse events will be evaluated using blood sample analysis and patient medical records.

研究概览

简要总结

The investigators wish to evaluate the association between tryptase values as well as c-Kit mutation and adverse effects in the course of immunotherapy. The investigators also intend to assess the effect of immunotherapy on tryptase levels.

详细描述

According to the presently available reports there is an association between systemic allergic responses to hymenoptera venom and elevated tryptase levels or c-Kit mutation. The presence of these findings may imply the existence of mast cell activation syndrome or mastocytosis. Therefore, baseline tryptase evaluation has become standard evaluation in patients with systemic responses. Meir Medical Center is the only hospital in Israel in which tryptase can be measured. Consequently, the Meir Clinic has accumulated considerable data with regards to tryptase levels in subjects with allergy to hymenoptera venom. The investigators wish to evaluate the association between tryptase values as well as c-Kit mutation and adverse effects in the course of immunotherapy. The investigators also intend to assess the effect of immunotherapy on tryptase levels.

研究设计

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

入排标准

年龄范围
4 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • history of systemic response to hymenoptera sting.
  • subject under current or planned venom immunotherapy.

排除标准

  • previously diagnosed mast cell disorder

结局指标

主要结局

The association between tryptase values/c-Kit mutation and immunotherapy adverse events will be evaluated using blood sample analysis and patient medical records.

时间窗: up to 12 months

次要结局

  • The association between tryptase values/c-Kit mutation and severity of index sting event will be evaluated using blood sample analysis and patient medical records.(up to 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

alon hershko

Chairman, Department of Medicine B

Meir Medical Center

研究点 (1)

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