Research of Biomarkers Associated With the Diagnosis and Severity of Bradykinin Angioedema

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Research of Biomarkers Associated With the Diagnosis and Severity of Bradykinin Angioedema

Conditions
-----------------
Angio Edema

Intervention / Treatment
-----------------
* Other: Biobanking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with bradykinin angioedema<br> | Other: Biobanking<br>* For patients included in BRADYDIAG study, 2 blood samples will be collected at enrollment (for group 1: bradykinin angioedema and for group 2: histamine-mediated angioedema) and at 1 year visit (for group 1 only: bradykinin angioedema).<br>* Other names: Biobanking without genetic analysis;|
| Patients with histamine-mediated angioedema<br> | Other: Biobanking<br>* For patients included in BRADYDIAG study, 2 blood samples will be collected at enrollment (for group 1: bradykinin angioedema and for group 2: histamine-mediated angioedema) and at 1 year visit (for group 1 only: bradykinin angioedema).<br>* Other names: Biobanking without genetic analysis;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare measurement by proteomics of proteins differentially expressed in the plasma by ANOVA t test | 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) | through study completion an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analyze the following biomarkers for diagnostic purposes in both groups. | analyze the following biomarkers for diagnostic purposes: C1 inhibitor quantity | Enrollment (for group 1 and group 2) + 1 year visit (for group 1 only) | 
| the value of plasma proteome markers and the markers mentioned above as predictors of the occurrence of attacks |  | at 1 year | 
| Implementation of a biobank to identify future biomarkers |  | Enrollment (for group 1 and group 2) + 1 year visit (for group 1 only) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Angioedema, Bradykinin, Biomarker, Biobanking