Clinical trial NCT04963634: Research of Biomarkers Associated With the Diagnosis and Severity of Bradykinin Angioedema
Official title: Research of Biomarkers Associated With the Diagnosis and Severity of Bradykinin Angioedema
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Angio Edema
Keywords: Angioedema
Bradykinin
Biomarker
Biobanking
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with bradykinin angioedema or histamine-mediated angioedema followed in internal medicine department of Lille University Hospital

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.


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

Primary outcomes:
measure: compare measurement by proteomics of proteins differentially expressed in the plasma by ANOVA t test
timeFrame: through study completion an average of 1 year
Secondary outcomes:
measure: analyze the following biomarkers for diagnostic purposes in both groups.
timeFrame: Enrollment (for group 1 and group 2) + 1 year visit (for group 1 only)
measure: the value of plasma proteome markers and the markers mentioned above as predictors of the occurrence of attacks
timeFrame: at 1 year
measure: Implementation of a biobank to identify future biomarkers
timeFrame: Enrollment (for group 1 and group 2) + 1 year visit (for group 1 only)
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: David Launay, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: