Angioedema Biomarker Research Study
Foundation For Rare Disease Research · with Institute for Asthma & Allergy, Virant Diagnostics, Inc. · NCT06210698
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 12–75 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Observational
- Target enrollment
- 600
- US sites recruiting
- 1
- Study start
- January 15, 2024
- Record last updated
- August 24, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Venipuncture
Conditions: Angioedema; Angioedemas, Hereditary; Urticaria; Mastocytosis; ACE Inhibitor-Induced Angioedema; C1 Inhibitor Deficiency; Systemic Mastocytoses; Indolent Systemic Mastocytosis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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.
Recruiting US locations
Institute for Asthma and Allergy Clinical Research
Wheaton, MD 20902
Site contact: Lili Wan, PhD
Study contacts (from the official record)
- Henry Li, MD, PhD · 877-888-2973 · henryli@allergyasthma.us
- Joseph Chiao, MD · 8778882973 · Jchiao@virantdx.com
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