Angioedema biomarker tests to help diagnose recurrent swelling

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, non-randomized observational study comparing novel and standard diagnostic assays using blood samples from people with recurrent angioedema and healthy volunteers. Up to 300 angioedema patients and 300 healthy controls will provide blood for tests across several platforms, including immunoassays, flow cytometry, mass spectrometry, and genetic sequencing. The goal is to determine whether combinations of tests can accurately distinguish different forms and etiologies of angioedema, with the aim of developing an affordable, accurate diagnostic approach. Participation involves venipuncture for blood collection and, optionally, a skin punch biopsy. Data will be used to evaluate diagnostic feasibility rather than to test a therapeutic intervention.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institute for Asthma and Allergy Clinical Research
  Wheaton, Maryland, United States Recruiting

Study contacts

• Study coordinator: Henry Li, MD, PhD
• Email: henryli@allergyasthma.us
• Phone: 877-888-2973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.