NCT06210698Recruiting
Angioedema Biomarker Research Study
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
This clinical trial aims to evaluate and compare novel and commercially available diagnostic assays through blood tests for the differential diagnosis and comprehensive assessment of patients experiencing recurrent angioedema attacks, including both urticarial and non-urticarial angioedema. The primary objective is to assess the efficiency of novel diagnostic assays, both individually and in combination, in comparison to currently available commercial tests. The ultimate goal is to establish the feasibility of developing an affordable and accurate laboratory test capable of diagnosing the diverse etiological manifestations of angioedema.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 8 Jan 2024
- Start date
- 15 Jan 2024
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Foundation For Rare Disease Research
- NCT number
- NCT06210698
What you commit to
- Study type: Observational
- Planned participants: 600
- From 15 Jan 2024 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking medications contraindicated for testing.
Other illness
- History of excessive bleeding after phlebotomy, e.g. Hemophilia.
Age
- Minor: 11 years of age or younger.
Other
- Cannot read or understand the informed consent form and instructions.
- Unable to perform the peripheral blood sample collection.
- Contraindication due to other health-related issues.
Who the study is looking for
- Understand and sign the informed consent form before starting any study procedure.
- Adult or Child: aged 12 years of age or older (consent must be signed by a single parent or legal guardian).
- Angioedema symptoms and signs by medical history, or previous laboratory diagnostic testing, or genetically proven cases (e.g. SERPING1 or other mutation). Patients can be on active medication for the treatment and prophylaxis of angioedema. Angioedema cases must be verified by a clinician from IAA.
- Able to perform and endure safely the collection of peripheral blood samples (venipuncture), or optionally agree to have additional testing via a skin punch biopsy.
Age in the registry: 12 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute for Asthma and Allergy Clinical Research Coordinator of this site? Confirm its status | Wheaton | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.