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Determination of Specific Biomarkers of Acute Attack of Angioedema Within Pediatric Population (BRADYKID)

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ClinicalTrials.gov Identifier: NCT02854397
Recruitment Status : Terminated (Recruitment difficulties)
First Posted : August 3, 2016
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

In emergency room, this is crucial to diagnose an acute attack of hereditary angioedema (HAE) to quickly provide the efficient treatment. Currently, there is no specific biomarker for acute attack of bradykinin-mediated angioedema to help clinicians for patient care. However, previous works are carried out for that purpose. All the potential candidate biomarkers must be validated in prospective studies to estimate their specificity and sensitivity values, and to understand their potential utility in patient care.

The main goal of this clinical trial is to estimate the diagnostic value of VE-cadherin in pediatric population, for the differential diagnosis between HAE crisis and angioedema resulting of mast cell activation crisis (the main differential diagnosis of HAE).


Condition or disease Intervention/treatment
Hereditary Angioedema Healthy Volunteers Other: blood sample

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Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Other
Time Perspective: Prospective
Actual Study Start Date : February 15, 2016
Actual Primary Completion Date : June 2020
Actual Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
patients with hereditary angioedema
A blood sample will be performed in crisis and 7 days after the crisis.
Other: blood sample
patients with angioedema resulting of mast cell activation
A blood sample will be performed in crisis and 7 days after the crisis.
Other: blood sample
healthy patients, without angioedema
A quantity of additional blood was taken from eligible patients who had a scheduled blood sample.
Other: blood sample



Primary Outcome Measures :
  1. VE-cadherin level [ Time Frame: Half a day ]
    For the diagnosis of acute attack of hereditary angioedema


Secondary Outcome Measures :
  1. Dosage of VE-cadherin (vascular endothelial) [ Time Frame: Half a day ]
    Analysis of the cleaved fragments from high molecular weight kininogen

  2. Dosage of Fc KHPM [ Time Frame: Half a day ]
    Analysis of the cleaved fragments from high molecular weight kininogen

  3. Dosage of D-dimer [ Time Frame: Half a day ]
    Analysis of the cleaved fragments from high molecular weight kininogen

  4. Dosage of Tryptase [ Time Frame: Half a day ]
    Analysis of the cleaved fragments from high molecular weight kininogen


Biospecimen Retention:   Samples Without DNA
Blood


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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with hereditary angioedema patients with angioedema resulting of mast cell activation healthy patients, without angioedema
Criteria

Inclusion Criteria:

For HAE: patient with a documented diagnosis of HAE:

  • type I (from an antigenic deficiency of the C1 esterase inhibitor) or type II (from a functional deficiency of the C1 esterase inhibitor). The existence of a mutation in SERPING1 was not necessary for the inclusion
  • HAE with normal C1-INH (ex type III) with a required mutation in FXII gene or with a typical family history of HAE diagnosed by a specialized physician belonging to CREAK network.

For AE resulting of mast cell activation: a documented diagnosis of AE resulting of mast cell activation included:

  • mastocytosis,
  • chronic spontaneous urticaria,
  • acute urticaria after exposure of allergen during allergy challenge tests,
  • mast cell activation syndrome.

For the control group:

  • composed of patients who presented a stabilized disease (that was not infectious, not auto-inflammatory or inflammatory disease and without implication of endothelial cells).

Exclusion Criteria:

  • Over 18 years or under 1 year.
  • Diagnosis of HAE with a normal C1 esterase inhibitor or AE of unknown aetiology.
  • Patients with HAE who received an acute attack treatment before the blood sample (the C1 esterase inhibitor concentrate or a bradykinin B2 receptor antagonist); patients with HAE who received a prophylactic treatment (danazol).
  • Patients who were treated by omalizumab or corticosteroid treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854397


Locations
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France
University hospital angers
Angers, France, 49933
University Hospital Besançon
Besançon, France, 25030
University hospital Bordeaux
Bordeaux, France, 33076
University hopital Clermont-Ferrand
Clermont-Ferrand, France, 63503
University Hospital Grenoble
Grenoble, France, 38043
University Hospital Lille
Lille, France, 59037
University Hospital Lyon
Lyon, France, 69677
University hospital Marseille
Marseille, France, 13385
University hospital Montpellier
Montpellier, France, 34295
University hospital Nancy
Nancy, France, 54500
General Hospital
Niort, France, 79021
university hospital Saint-Antoine (AP-HP)
Paris, France, 75571
University hospital Rouen
Rouen, France, 76031
University hospital Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Anne Pagnier University Hospital, Grenoble
Publications:
Parisi G, Chiarelli A, Squadrone NP, Galante E. Hereditary angioedema, a rare cause of recurrent abdominal pain. A report of 2 clinical cases and comments of a general nature Allergy Asthma Proc. 2013 Jul-Aug;34(4):312-27
Brevet: w/o 2008 062314 circulating ve-cadherin as a predictive marker of sensitivity or resistance to anti-tumoral treatment, and improved method for the detection of soluble proteins.

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02854397    
Other Study ID Numbers: 38RC15.180
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hereditary Complement Deficiency Diseases
Primary Immunodeficiency Diseases
Genetic Diseases, Inborn
Immunologic Deficiency Syndromes