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Evaluation of Anti-neutrophil Cytoplasm Antibodies Test

NCT04719715 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2021-01-22

No results posted yet for this study

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) [email protected]

Conditions

  • Immunological Testing in Small-vessel Vasculitis

Interventions

DIAGNOSTIC_TEST

Indirect immunofluorescence (IIF) , myeloperoxidase antibody(MPO)- and anti-proteinase 3 (PR3-) ANCA immunoassays

Measurement and evaluation of the ANCA testing

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Principal Investigators

  • Mai Mansour · Sohag University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-28
Primary Completion
2022-02-28
Completion
2023-02-28

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04719715 on ClinicalTrials.gov