Research of Biomarkers Associated With the Diagnosis and Severity of Bradykinin Angioedema (NCT04963634) | Clinical Trial Compass
TerminatedNot Applicable
Research of Biomarkers Associated With the Diagnosis and Severity of Bradykinin Angioedema
Stopped: Only one enrollment during the study's enrollment period. Stopped by the sponsor.
France1 participantsStarted 2022-01-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
compare measurement by proteomics of proteins differentially expressed in the plasma by ANOVA t test
Timeframe: through study completion an average of 1 year