Status:
NOT_YET_RECRUITING
Angioedema Biomarker Research Study
Lead Sponsor:
Foundation For Rare Disease Research
Collaborating Sponsors:
Institute for Asthma & Allergy
Virant Diagnostics, Inc.
Conditions:
Angioedema
Angioedemas, Hereditary
Eligibility:
All Genders
12-75 years
Brief Summary
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 experien...
Detailed Description
Purpose: The purpose of this prospective non-interventional non-randomized diagnostic study is to first identify patients with recurrent angioedema attacks, then collect their blood samples (venipunct...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06210698
Start Date
January 15 2024
End Date
February 1 2026
Last Update
January 18 2024
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