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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A03306-33 | Other Identifier | ID-RCB number,ANSM |
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Only one enrollment during the study's enrollment period. Stopped by the sponsor.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with bradykinin angioedema |
| ||
| Patients with histamine-mediated angioedema |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biobanking | Other | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Group 2 : Patients with histamine-mediated angioedema
Exclusion Criteria:
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Patients with bradykinin angioedema or histamine-mediated angioedema followed in internal medicine department of Lille University Hospital
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| Name | Affiliation | Role |
|---|---|---|
| David Launay, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hop Claude Huriez Chu Lille | Lille | 59037 | France |
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| ID | Term |
|---|---|
| D000799 | Angioedema |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
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| ID | Term |
|---|---|
| D005820 | Genetic Testing |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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serum and plasma
|
| 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) |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |