Angioedema Biomarker Research Study

NCT06210698 | Unknown DMC

• 1 other identifier: Virant-A001
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Angioedema; Angioedemas, Hereditary; Urticaria; Mastocytosis; ACE Inhibitor-Induced Angioedema; C1 Inhibitor Deficiency; Systemic Mastocytoses; Indolent Systemic Mastocytosis

Keywords

angioedema; c1-inhibitor deficiency; C1-inhibitor dysfunction; hereditary angioedema; HAE; ACE Inhibitor-induced angioedema; serum tryptase; mastocytosis; systemic mastocytosis; indolent systemic mastocytosis

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Secondary Outcomes (4)

• Genetic analysis of angioedema versus non-angioedema affected populations

  2 years

• Development of novel Bradykinin biomarkers

  2 years

• Immunoassay laboratory developed tests for angioedema

  2 years

• Lymphocyte profile studies

  2 years

Study Arms (2)

Recurrent Angioedema

Broad definition: Angioedema due to urticaria (histaminergic/mast-cell) or non-urticarial (non-histaminergic) etiology Narrow definition: non-urticarial angioedema - distinguishing between C1-Inhibitor deficiency/dysfunction, and Angioedema with normal levels of C1-Inhibitor.

Diagnostic Test: Venipuncture

Healthy Subjects

Broad definition: No medical history of angioedema of any kind, including urticaria (histaminergic) or drug-induced angioedema (e.g. ACE-Inhibitor angioedema)

Diagnostic Test: Venipuncture

Interventions

Venipuncture DIAGNOSTIC_TEST

venipuncture

Healthy Subjects; Recurrent Angioedema

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foundation For Rare Disease Research: lead
• Institute for Asthma & Allergy: collaborator
• Virant Diagnostics, Inc.: collaborator
• MedBio Reference Laboratories, Inc.: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood, Plasma, Serum

MeSH Terms

Conditions

Angioedema; Angioedemas, Hereditary; Urticaria; Mastocytosis; Mastocytosis, Systemic

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Mast Cell Activation Disorders

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Lili Wan, PhD

  Institute for Asthma & Allergy

  STUDY DIRECTOR

Central Study Contacts

Henry Li, MD, PhD

CONTACT

877-888-2973; henryli@allergyasthma.us

Joseph Chiao, MD

CONTACT

8778882973; Jchiao@virantdx.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: January 15, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 2 years