Research of Biomarkers Associated With the Diagnosis and Severity of Bradykinin Angioedema (BRADYDIAG)

April 29, 2026 updated by: University Hospital, Lille

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1

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
      • Lille, France, 59037
        • Hop Claude Huriez Chu Lille

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with bradykinin angioedema or histamine-mediated angioedema followed in internal medicine department of Lille University Hospital

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with bradykinin angioedema
Other: 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 Names:
  • Biobanking without genetic analysis
Patients with histamine-mediated angioedema
Other: 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 Names:
  • Biobanking without genetic analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compare measurement by proteomics of proteins differentially expressed in the plasma by ANOVA t test
Time Frame: through study completion an average of 1 year
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
analyze the following biomarkers for diagnostic purposes in both groups.
Time Frame: Enrollment (for group 1 and group 2) + 1 year visit (for group 1 only)
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
Time Frame: at 1 year
at 1 year
Implementation of a biobank to identify future biomarkers
Time Frame: Enrollment (for group 1 and group 2) + 1 year visit (for group 1 only)
Enrollment (for group 1 and group 2) + 1 year visit (for group 1 only)

Collaborators and Investigators

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

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: David Launay, MD,PhD, University Hospital, Lille

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)

January 22, 2022

Primary Completion (Actual)

July 15, 2025

Study Completion (Actual)

July 15, 2025

Study Registration Dates

First Submitted

June 2, 2021

First Submitted That Met QC Criteria

July 5, 2021

First Posted (Actual)

July 15, 2021

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020_59
  • 2020-A03306-33 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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