Clinical trial · Observational
Angioedema Biomarker Research Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ACE Inhibitor-Induced Angioedema | — | UNRESOLVED | — |
| Angioedema | — | UNRESOLVED | — |
| Angioedemas, Hereditary | — | UNRESOLVED | — |
| C1 Inhibitor Deficiency | — | UNRESOLVED | — |
| Indolent Systemic Mastocytosis | Indolent Systemic Mastocytosis | ONTOLOGY_EXACT | 0.98 |
| Mastocytosis | Mastocytosis | ONTOLOGY_EXACT | 0.98 |
| Systemic Mastocytoses | — | UNRESOLVED | — |
| Urticaria | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Venipuncture | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Recurrent Angioedema
- description
- Broad definition: Angioedema due to urticaria (histaminergic/mast-cell) or non-urticarial (non-histaminergic) etiology Narrow definition: non-urticarial angioedema - distinguishing between C1-Inhibitor deficiency/dysfunction, and Angioedema with normal levels of C1-Inhibitor.
- interventionNames
- Diagnostic Test: Venipuncture
- label
- Healthy Subjects
- description
- Broad definition: No medical history of angioedema of any kind, including urticaria (histaminergic) or drug-induced angioedema (e.g. ACE-Inhibitor angioedema)
- interventionNames
- Diagnostic Test: Venipuncture
Primary outcomes (1)
- measure
- Novel versus traditional diagnostic blood test for angioedema
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Minor: 11 years of age or younger. * Cannot read or understand the informed consent form and instructions. * Unable to perform the peripheral blood sample collection. * Taking medications contraindicated for testing. * History of excessive bleeding after phlebotomy, e.g. Hemophilia. * Contraindication due to other health-related issues.
References
Publications (0)
Data not yet available