Evaluation of Anti-neutrophil Cytoplasm Antibodies Test

• Conditions: Immunological Testing in Small-vessel Vasculitis
• Interventions: Diagnostic Test: Indirect immunofluorescence (IIF) , myeloperoxidase antibody(MPO)- and anti-proteinase 3 (PR3-) ANCA immunoassays

• Registration Number: NCT04719715
• Lead Sponsor: Sohag University

Brief Summary

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

Detailed Description

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.).

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-19
• Last Update Submitted: 2021-01-19
• Study First Posted: 2021-01-22
• Last Update Posted: 2021-01-22
• Study Start: 2021-02
• Primary Completion: 2022-02
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

.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)

Exclusion Criteria

.Patients younger than 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases with ANCA vasculitis	Indirect immunofluorescence (IIF) , myeloperoxidase antibody(MPO)- and anti-proteinase 3 (PR3-) ANCA immunoassays	Indirect immunofluorescence (IIF) will be performed as well as myeloperoxidase antibody(MPO)- and anti-proteinase 3 (PR3-) ANCA immunoassays and evaluated
Controls with autoimmune diseases other than ANCA vasculitis	Indirect immunofluorescence (IIF) , myeloperoxidase antibody(MPO)- and anti-proteinase 3 (PR3-) ANCA immunoassays	Indirect immunofluorescence (IIF) will be performed as well as myeloperoxidase antibody(MPO)- and anti-proteinase 3 (PR3-) ANCA immunoassays and evaluated

Primary Outcome Measures

Name	Time	Method
Anti-proteinase 3 antibody (PR3), anti-myeloperoxidase (MPO) antibody presence in patients with small-vessel vasculitis versus patients without vasculitis	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

Trial Locations

Locations (1)

Kagawa univeristy; 🇯🇵 Miki, Kagawa, Japan