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.
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.
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.
The collection of medical history and peripheral blood (venipuncture) to perform multiple diagnostic assays from patients experiencing recurrent angioedema attacks, including both urticarial and non-urticarial angioedema. Healthy volunteers will not have a medical history of angioedema.
Cohort
Prospective
Venipuncture
Diagnostic testvenipuncture
Novel versus traditional diagnostic blood test for angioedema
Determining whether novel test methods can be more efficient than currently available or traditional laboratory test for angioedema diagnosis
Genetic analysis of angioedema versus non-angioedema affected populations
Genetic testing that include know angioedema mutations, such as SERPING1
Development of novel Bradykinin biomarkers
Mass Spectrometry analysis of plasma for bradykinin metabolites
Immunoassay laboratory developed tests for angioedema
development of novel immunoassay biomarkers, such as the detection of cleaved HMWK
Lymphocyte profile studies
Determine whether the immune system has a role in angioedema attacks
Click on the lead sponsor to view all of their trials.
Foundation For Rare Disease Research
Lead sponsor
Institute for Asthma & Allergy
Collaborator
Virant Diagnostics, Inc.
Collaborator
MedBio Reference Laboratories, Inc.
Collaborator
