Investigation of the Frequency of Hereditary Hyper Alpha-tryptasemia in Patients With Elevated Basal Tryptasemia (Protocol HaT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Prevalence of hereditary hyper alpha-tryptasemia
研究概览
简要总结
The aim of the study is to assess the number of patients with elevated blood tryptase for whom this elevation could be linked to a hereditary alpha-tryptase secretion abnormality or hyper-alpha-tryptasemia. This information will enable to better optimize the management and follow-up of patients who have experienced hypersensitivity reactions and have elevated basal blood tryptase levels. The patients will be offered the opportunity to take part in the study. If they consent to participate, they will be tested for hereditary hyper-alpha-tryptasemia. A blood sampling will be performed in the center. A few weeks after, the patient will be informed about the blood sample result during a medical consultation organized in the center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who came in the pneumoallergology department of the CHU de Nice since January 2014 for an allergological workup
- •Patients who have received at least one basal tryptase assay, according to recommendations
- •informed consent signature
排除标准
- •High tryptasemia (≥ 8ng/ml) synchronous with anaphylactic reaction and unconfirmed basally
- •Known diagnosis of systemic mastocytosis
研究组 & 干预措施
Samples Without DNA
Patients who came to the pneumoallergology department of the CHU de Nice since January 2014 for an allergological workup and with tryptasemia was ≥ 8ng/ml (at least once in patient history).
干预措施: Serum (Genetic)
结局指标
主要结局
Prevalence of hereditary hyper alpha-tryptasemia
时间窗: at inclusion
Analysis machine by PCR
次要结局
- Phenotyping our patient cohort(at 36 months)
- Set up a serotheque to support scientific and medical projects in this field(At inclusion)