Angioedema Biomarker Research Study

Part of paid clinical trials in Wheaton, Maryland.

Sponsor
Foundation For Rare Disease Research
Study ID
NCT06210698
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
12 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Venipuncture — DIAGNOSTIC_TEST
    venipuncture

Study Details

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.

Key Dates

First listed
Jan 18, 2024
Start date
Jan 15, 2024
Status verified
Aug 2026
Primary completion
Jul 31, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
600 participants (estimated)

Arms

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

Primary Outcome Measure

Novel versus traditional diagnostic blood test for angioedema [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Institute for Asthma and Allergy Clinical ResearchWheatonMaryland20902
Lili Wan, PhD
Henry LI, MD (PRINCIPAL_INVESTIGATOR)

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Institute for Asthma and Allergy Clinical Research· Wheaton, MD

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