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Angioedema Biomarker Research Study

Recruitingn/aAges 12 Years - 75 YearsAllFoundation For Rare Disease Research
NCT06210698 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Venipuncture
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Where

1 site
Institute for Asthma and Allergy Clinical Research
Wheaton, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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