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TerminatedNCT04963634BRADYDIAGUpdated May 5, 2026

Research of Biomarkers Associated With the Diagnosis and Severity of Bradykinin Angioedema

An observational study in Angio Edema, sponsored by University Hospital, Lille. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by University Hospital, Lille · Observational

Why this study was terminated
Only one enrollment during the study's enrollment period. Stopped by the sponsor.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1
Ages
18 Years and older
Sex
All
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Study summary

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.

02

Conditions studied

  • Angio Edema

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Keywords

  • Angioedema
  • Bradykinin
  • Biomarker
  • Biobanking
03

In context

Angioedema

69 studies on the registry are indexed under Angioedema; 16 are open to participants now.

This study's enrollment of 1 is below the median of 181 across 19 observational studies indexed under Angioedema.

Browse Angioedema studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1 participant (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Patients with bradykinin angioedema

    Other: Biobanking

  • Patients with histamine-mediated angioedema

    Other: Biobanking

Interventions

  • OtherBiobanking

    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).

    Also known as: Biobanking without genetic analysis

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What researchers measure

Primary outcomes

  1. 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)

    Time frame: through study completion an average of 1 year

Secondary outcomes

  1. analyze the following biomarkers for diagnostic purposes in both groups.

    analyze the following biomarkers for diagnostic purposes: C1 inhibitor quantity

    Time frame: Enrollment (for group 1 and group 2) + 1 year visit (for group 1 only)

  2. the value of plasma proteome markers and the markers mentioned above as predictors of the occurrence of attacks

    Time frame: at 1 year

  3. Implementation of a biobank to identify future biomarkers

    Time frame: Enrollment (for group 1 and group 2) + 1 year visit (for group 1 only)

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Study locations

1 site
  • Hop Claude Huriez Chu Lille
    Lille, 59037, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04963634
Responsible party
Sponsor
First posted
Jul 15, 2021
Start date
Jan 22, 2022
Primary completion
Jul 15, 2025
Completion
Jul 15, 2025
Last update
May 5, 2026

Study contacts

David Launay, MD,PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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