Actively Recruiting

Age: 18Years +
All Genders
ID05984394

Evaluation of Antigen-specific Th1 and Th17 Cells, ILC and MAIT in Patients With Antisynthetase Syndrome and Interstitial Lung Disease

Led by Central Hospital, Nancy, France · Updated on 2024-08-27

24

Participants Needed

6

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating antisynthetase syndrome (AS), a rare autoimmune condition involving muscle inflammation and lung disease. This study focuses on patients newly diagnosed with AS and interstitial lung disease (ILD), aiming to understand how specific immune cells in the lungs relate to disease severity and treatment response over six months. The study examines immune cell types like Th1, Th17, innate lymphoid cells (ILC), and mucosal-associated invariant T cells (MAIT) that may influence disease progression. Participants will undergo testing to identify antigen-specific Th1 and Th17 cells, ILC, and MAIT cells in bronchoalveolar fluid (BAL) at the time of ILD diagnosis. This observational study does not involve experimental treatments but monitors these immune markers to assess their connection to lung disease severity. The study tracks changes in lung function and immune cell levels from diagnosis through six months of standard treatment. During the study, participants will provide samples for immune cell analysis and have lung function tests such as forced vital capacity (FVC) measured at baseline and after six months. Researchers will evaluate how initial immune cell presence correlates with changes in lung function and overall disease activity. The study lasts at least six months, with ongoing clinical assessments to monitor disease progression and response to therapy.

CONDITIONS

Brief Title

Evaluation of Antigen-specific T Cells in Patients With Antisynthetase Syndrome and Interstitial Lung Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient with new diagnosis of antisynthetase syndrome and interstitial lung disease
Not Eligible

You will not qualify if you...

  • Patient with interstitial lung disease differential diagnosis
  • Corticosteroid treatment, immunosuppressive or immunomodulatory drugs in the past 3 months before diagnosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline (Day 0)

Participants undergo diagnostic tests including collection of BAL antigen-specific Th1 and Th17 cells, ILC and MAIT to evaluate their condition.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 6 months

Participants are monitored for changes in lung function and disease activity within 6 months after diagnosis.

Follow-up visits within 6 months after diagnosis

Trial Site Locations

Total: 6 locations

1

Bernard Bonnotte

Dijon, France

Actively Recruiting

2

Julien Campagne

Metz, France

Actively Recruiting

3

Paul Decker

Nancy, France

Actively Recruiting

4

Olivier Benveniste

Paris, France

Not Yet Recruiting

5

Loïs Bolko

Reims, France

Actively Recruiting

6

Alain Meyer

Strasbourg, France

Actively Recruiting

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Research Team

P

Paul Decker, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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