Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Patient with new diagnosis of antisynthetase syndrome and interstitial lung disease
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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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