Research of Biomarkers Associated With the Diagnosis and Severity of Bradykinin Angioedema
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- compare measurement by proteomics of proteins differentially expressed in the plasma by ANOVA t test
研究概览
简要总结
The unpredictable nature of the attacks is one of the essential characteristics of bradykinin angioedema. The two main difficulties for physicians managing a patient with bradykinin angioedema are to make the diagnosis and anticipate the severity.
Biomarkers can be used to diagnose, guide treatment, or predict the severity of a disease. However, the identification of biomarkers is currently difficult in bradykinin both for diagnosis and prognosis. While measurement of C4 and C1 inhibitor (quantitative and functional assays) allows the diagnosis of bradykinin angioedema due to C1 inhibitor deficiency, whether genetic or acquired, many patients with normal C1 inhibitor bradykinin angioedema, either hereditary or acquired, are still difficult to diagnose. For patients with hereditary angioedema with C1-inhibitor deficiency, there is no biomarker currently available to predict the severity. Any biomarker that could improve the diagnosis on the one hand, and improve the prediction of the frequency and severity of the response to treatment on the other hand, would obviously be extremely useful. The aim of our study is to assess the existence possible biomarkers for diagnosis and prognosis of bradykinin angioedema.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Group 1 : Patients with bradykinin angioedema
- •Patient with biologically proven hereditary angioedema with C1 inhibitor deficiency,
- •Or a patient with bradykinin angioedema related to a plasminogen or factor XII mutation,
- •Or patients with bradykinin angioedema related to ACE inhibitors or ARB2,
- •Or patient with acquired bradykinin angioedema due to C1 inhibitor deficiency,
- •Age > or = 18 years with the capacity to understand the requirements of the study and to give a non-opposition
- •Having a blood collection scheduled as part of routine care
- •Being insured by social security
- •Group 2 : Patients with histamine-mediated angioedema
- •Patient with idiopathic histamine angioedema as determined by the referring physician
- •Age > or = 18 years with the capacity to understand the requirements of the study and to give a non-opposition
- •Having a blood collection scheduled as part of routine care
- •Being insured by social security
排除标准
- •Minors or protected adults,
- •Pregnant or breastfeeding woman,
- •Person deprived of liberty,
- •Person in an emergency situation,
- •Person having refused or unable to give their non-opposition
结局指标
主要结局
compare measurement by proteomics of proteins differentially expressed in the plasma by ANOVA t test
时间窗: through study completion an average of 1 year
to evaluate the contribution of a plasma proteomic signature including albumin, gammaglobulin and alpha macroglobulin the plasma proteome of two group: Enrollment (for group 1 and group 2) + 1 year visit (for group 1 only)
次要结局
- the value of plasma proteome markers and the markers mentioned above as predictors of the occurrence of attacks(at 1 year)
- analyze the following biomarkers for diagnostic purposes in both groups.(Enrollment (for group 1 and group 2) + 1 year visit (for group 1 only))
- Implementation of a biobank to identify future biomarkers(Enrollment (for group 1 and group 2) + 1 year visit (for group 1 only))