Evaluation of ANCA Testing by Antigen Specific Assays in Small Vessel Vasculitis
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Anti-proteinase 3 antibody (PR3), anti-myeloperoxidase (MPO) antibody presence in patients with small-vessel vasculitis versus patients without vasculitis
研究概览
简要总结
Anti-neutrophil cytoplasm antibodies (ANCA) are defined as important serological markers for the diagnosis of some forms of small vessel vasculitis, including granulomatosis with polyangiitis (GPA) , microscopic polyangiitis(MPA) and to a lesser extent Churg -Strauss syndrome or Eosinophilic granulomatosis with polyangiitis (EGPA).So they are called ANCA-associated vasculitis(AAV).
An international consensus statement for ANCA testing statement was issued in 2017 and states that the antigen specific immunoassays can be used for the accurate diagnosis of ANCA-associated vasculitis without the need for indirect immunofluorescence(IIF). In the present study we will test whether the antigen specific assays screening is a valuable alternative to IIF confirming with immunoassay for the diagnosis of AAV on a number of patients and controls.
Aim To evaluate the performance of the recommended strategy for the detection of ANCA based on screening with antigen specific immunoassays on a number of AAV patients and relevant disease controls In Kagawa university hospital (rheumatology department).
Patients and methods This is a prospective study will be conducted at the department of rheumatology in Kagawa university hospital in which consecutive samples will be included from patients suspected to have AAV; patients subsequently identified as having AAV will be included as AAV patients, while patients in which the diagnosis AAV is rejected, will be included as disease controls. PR3-and MPO-ANCA will be performed using assays from Medical & Biological Laboratories Co (Anchor CLEIA) isayama.takuya@mbl.co.jp
详细描述
To evaluate the performance of the recommended strategy for the detection of ANCA based on screening with antigen specific immunoassays on a number of AAV patients and relevant disease controls (i. e., patients for whom ANCA would be requested in the context of small-vessel vasculitis such as patients with infections, drug-induced diseases, connective tissue disease, etc.).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •.All patients included must be older than 18 years and able to give informed consent.
- •Classification criteria and nomenclature for AAV are from the American College of Rheumatology
- •Serum sampling should be done before initiation of immunosuppressive treatment or no later than 2 weeks after onset of low-medium dose of immunosuppressive treatment (but this should be documented)
排除标准
- •.Patients younger than 18 years old
结局指标
主要结局
Anti-proteinase 3 antibody (PR3), anti-myeloperoxidase (MPO) antibody presence in patients with small-vessel vasculitis versus patients without vasculitis
时间窗: within two weeks of immunosuppressive treatment not after that
Antibodies are detected using chemiluminescent enzyme immunoassay (CLEIA).Values above 3.5 u/ml are considered positive
次要结局
未报告次要终点
研究者
Mai Mahmoud Fahmy Mansour
Assistant lecturer of Rheumatology, Rehabilitation and Physical Medicine
Sohag University
