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Evaluation of Circulating Neutrophils in Antisynthetase Syndrome

NCT05989399 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 89

Last updated 2026-04-20

No results posted yet for this study

Summary

Antisynthetase syndrome (ASyS) is a rare and heteregeneous overlapping connective tissue disease, characterized by myositis, interstitial lung disease (ILD), joint involvement, Raynaud's phenomenon and cutaneous manifestations ("mechanic's hands"). Over 50% of patients develop ILD, which is the leading cause of death.

The role of neutrophils - innate immune cells involved in inflammatory processes and induced in particular by cytokines of the Th17 pathway - during AS is unknown. Direct pathogenic role of neutrophils has been described during idiopathic inflammatory myopathies, with an increase of netosis correlated with disease activity and muscle damage. During ASyS, a higher number of alveolar neutrophils has been observed in patients with rapidly progressive ILD.

There are few data on the specific evaluation of circulating neutrophils in ASyS. Investigators suppose that circulating neutrophils level could represent a simple and accessible severity biomarker in patients with ASyS.

The main objective is to evaluate the diagnostic performance of the circulating neutrophils level (\> 7000/mm3) at diagnosis on ASyS severity.

The secondary objectives are:

* to define a threshold for circulating neutrophils levels at diagnosis allowing to predict ASyS severity and to assess the diagnostic performance of this threshold.
* to define a threshold for the circulating neutrophils/lymphocytes ratio at diagnosis allowing to predict ASyS severity and to assess the diagnostic performance of this threshold.
* to study the correlation between the level of circulating neutrophils and ASyS severity at diagnosis of the disease.
* to study the correlation between the circulating neutrophils/lymphocytes ratio and ASyS severity at diagnosis of the disease.
* to compare the circulating neutrophils level at ASyS diagnosis and after 1 year of treatment.
* to compare the circulating neutrophils/lymphocytes ratio at ASyS diagnosis and after 1 year of treatment.
* to compare patients characteristics according to ASyS severity at diagnosis.
* to compare BAL fluid neutrophils level according to ILD severity at ASyS diagnosis in patients with ILD.
* to compare BAL fluid neutrophils/lymphocytes ratio according to ILD severity at ASyS diagnosis in patients with ILD.

Conditions

  • Antisynthetase Syndrome

Interventions

DIAGNOSTIC_TEST

circulating neutrophils

evaluation of circulating neutrophils level

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Principal Investigators

  • Paul Decker, MD · CHU NANCY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2026-01-10
Completion
2026-01-10

Countries

  • France

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 NCT05989399 on ClinicalTrials.gov