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

November 16, 2020 updated by: University Hospital, Grenoble

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • University Hospital Angers
      • Besançon, France, 25030
        • University Hospital Besancon
      • Bordeaux, France, 33076
        • University Hospital Bordeaux
      • Clermont-Ferrand, France, 63503
        • University hopital Clermont-Ferrand
      • Grenoble, France, 38043
        • University Hospital Grenoble
      • Lille, France, 59037
        • University Hospital Lille
      • Lyon, France, 69677
        • University Hospital Lyon
      • Marseille, France, 13385
        • University hospital Marseille
      • Montpellier, France, 34295
        • University Hospital Montpellier
      • Nancy, France, 54500
        • University Hospital Nancy
      • Niort, France, 79021
        • General Hospital
      • Paris, France, 75571
        • university hospital Saint-Antoine (AP-HP)
      • Rouen, France, 76031
        • University Hospital Rouen
      • Toulouse, France, 31059
        • University Hospital Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with hereditary angioedema patients with angioedema resulting of mast cell activation healthy patients, without angioedema

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VE-cadherin level
Time Frame: Half a day
For the diagnosis of acute attack of hereditary angioedema
Half a day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dosage of VE-cadherin (vascular endothelial)
Time Frame: Half a day
Analysis of the cleaved fragments from high molecular weight kininogen
Half a day
Dosage of Fc KHPM
Time Frame: Half a day
Analysis of the cleaved fragments from high molecular weight kininogen
Half a day
Dosage of D-dimer
Time Frame: Half a day
Analysis of the cleaved fragments from high molecular weight kininogen
Half a day
Dosage of Tryptase
Time Frame: Half a day
Analysis of the cleaved fragments from high molecular weight kininogen
Half a day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Anne Pagnier, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2016

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Actual)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC15.180

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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