Angioedema Biomarker Research Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Novel versus traditional diagnostic blood test for angioedema
研究概览
简要总结
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.
详细描述
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 (venipuncture) and ultimately send the samples to specialized laboratories to perform multiple diagnostic assays, novel and traditional, that can distinguish the various forms of angioedema (urticaria and non-urticarial symptoms and signs), and healthy subjects.
Methods and Materials: Blood specimen collection from a total of 300 patients with recurrent angioedema attacks, and 300 healthy volunteers without a history of angioedema attacks. Laboratory testing will include assays on multiple platforms. Complement testing via immunoassay and biochemistry techniques. Flow Cytometry using multiple markers. Mass Spectrometry that includes bradykinin metabolite and histamine detection. Molecular Genetics include Sanger sequencing, Next Generation Sequencing (NGS), and digital PCR.
Patient population: Study participants to be screened who have a history of recurrent angioedema incidents as well as a population of healthy subjects. A medical history will be documented after obtaining informed patient consent to enter into the clinical trial. Each enrolled participant will have blood collected as whole blood, plasma and serum via venipuncture.
Eligibility criteria (inclusion) for sample collection (angioedema subject):
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Novel versus traditional diagnostic blood test for angioedema
时间窗: 2 years
Determining whether novel test methods can be more efficient than currently available or traditional laboratory test for angioedema diagnosis
次要结局
- Lymphocyte profile studies(2 years)
- Development of novel Bradykinin biomarkers(2 years)
- Genetic analysis of angioedema versus non-angioedema affected populations(2 years)
- Immunoassay laboratory developed tests for angioedema(2 years)