Research of Biomarkers Associated With the Diagnosis and Severity of Bradykinin Angioedema
NCT ID: NCT04963634
Last Updated: 2022-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
110 participants
OBSERVATIONAL
2022-01-22
2026-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Patients with bradykinin angioedema
Biobanking
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).
Patients with histamine-mediated angioedema
Biobanking
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).
Interventions
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Biobanking
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant or breastfeeding woman,
* Person deprived of liberty,
* Person in an emergency situation,
* Person having refused or unable to give their non-opposition
18 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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David Launay, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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Hop Claude Huriez Chu Lille
Lille, , France
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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2020-A03306-33
Identifier Type: OTHER
Identifier Source: secondary_id
2020_59
Identifier Type: -
Identifier Source: org_study_id
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