Clinical Evaluation of Flow CAST® as an Aid in the Diagnosis of Peanut Allergy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 245
- 主要终点
- Clinical sensitivity of Flow CAST® with respect to a population of subjects with confirmed peanut allergy
研究概览
简要总结
This will be a multi-center, prospective evaluation, conducted at a minimum of four (4) U.S. sites. Sites will enroll peanut allergic subjects, subjects with allergies other than peanut and apparently healthy non-atopic control subjects and collect blood samples for testing using Flow CAST® and the comparative ImmunoCAP sIgE test.
详细描述
Study subjects will be enrolled into one of the following 3 groups: healthy non-atopic subjects with no history of allergies, atopic subjects with confirmed peanut allergy, atopic subjects with a diagnosed allergy but confirmed negative for peanut allergy.
Subgroup analysis will be performed for each of the above categories.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individual undergoing a blood draw
- •Individual willing and able to provide two additional tubes of blood (3ml each tube) for research purposes
- •Individual or legal guardian will and able to sign the informed consent form to participate in the study
排除标准
- •Individual has undergone immunotherapy for peanuts or other identified allergens that have been shown to cause allergic symptoms
- •Individual has been exposed to systemically administered glucocorticoids within the last 24 hours.
- •Individual has been recently exposed to small molecule immunosuppressive medications
- •Individual has been recently exposed to treatment with biologics interfering with the type-I allergic pathway
- •Individual is currently involved in another "allergy treatment related" clinical research study
结局指标
主要结局
Clinical sensitivity of Flow CAST® with respect to a population of subjects with confirmed peanut allergy
时间窗: Within 48 hours after sample collection
Clinical specificity of Flow CAST® with respect to a population of apparently healthy non-atopic subjects
时间窗: Within 48 hours after sample collection
次要结局
未报告次要终点