Angio EdemaBRADYDIAGNCT04963634
Research of Biomarkers Associated With the Diagnosis and Severity of Bradykinin Angioedema
An observational study of Angio Edema, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angio Edema
- What is being tested?
- Biobanking
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2022to 15 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with bradykinin angioedema or histamine-mediated angioedema followed in internal medicine department of Lille University Hospital
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Angio Edema
- Being tested
- Biobanking
- Keywords
- Angioedema, Bradykinin, Biomarker, Biobanking
- Medical subject headings
- Angioedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiobankingOther
Also called Biobanking without genetic analysis
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients with bradykinin angioedema | Not described Receives: Other: Biobanking | |
| Patients with histamine-mediated angioedema | Not described Receives: Other: Biobanking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion an average of 1 year
Secondary outcomes (3)
analyze the following biomarkers for diagnostic purposes in both groups.
analyze the following biomarkers for diagnostic purposes: C1 inhibitor quantity
Measured: 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
Measured: at 1 year
Implementation of a biobank to identify future biomarkers
Measured: Enrollment (for group 1 and group 2) + 1 year visit (for group 1 only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start22 Jan 2022
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Why it stopped: Only one enrollment during the study's enrollment period. Stopped by the sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angio EdemaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Launay, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963634
- Sponsor's protocol ID
- 2020_59
- Other IDs
- 2020-A03306-33
- Acronym
- BRADYDIAG
- Status last verified
- Apr 2026
- First submitted
- 2 Jun 2021
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of Biomarkers Associated With the Diagnosis and Severity of Bradykinin Angioedema
- ClinicalTrials.gov ID
- NCT04963634
- Acronym / sponsor ID
- BRADYDIAG / 2020_59
- Conditions
- Angio Edema
- Keywords
- Angioedema, Bradykinin, Biomarker, Biobanking
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Only one enrollment during the study's enrollment period. Stopped by the sponsor.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 22 Jan 2022 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with bradykinin angioedema | – | Other: Biobanking |
| Patients with histamine-mediated angioedema | – | Other: Biobanking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bradykinin angioedema or histamine-mediated angioedema followed in internal medicine department of Lille University Hospital
Key inclusion criteria (13 listed)
- 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,
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiobankingAlso: Biobanking without genetic analysisFor 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 | Patients with bradykinin angioedema, Patients with histamine-mediated angioedema |
Primary outcome
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)
3 secondary outcomes
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)
the value of plasma proteome markers and the markers mentioned above as predictors of the occurrence of attacks
Time frame: 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)
Results and safety
The study was stopped early (reason given: Only one enrollment during the study's enrollment period. Stopped by the sponsor.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Launay, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angio Edema, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Only one enrollment during the study's enrollment period. Stopped by the sponsor.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.