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临床试验/NCT04719715
NCT04719715Unknown不适用

Evaluation of ANCA Testing by Antigen Specific Assays in Small Vessel Vasculitis

Sohag University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年2月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mai Mahmoud Fahmy Mansour

Assistant lecturer of Rheumatology, Rehabilitation and Physical Medicine

Sohag University

研究点 (1)

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