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

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ClinicalTrials.gov Identifier: NCT05984394

Recruitment Status : Not yet recruiting

First Posted : August 9, 2023

Last Update Posted : August 9, 2023

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Paul DECKER, MD, Central Hospital, Nancy, France

Tracking Information

First Submitted Date

August 2, 2023

First Posted Date

August 9, 2023

Last Update Posted Date

August 9, 2023

Estimated Study Start Date

October 31, 2023

Estimated Primary Completion Date

October 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

BAL antigen-specific Th1 and Th17 cells [ Time Frame: baseline (J0) ]
BAL antigen-specific Th1 and Th17 cells percentages among BAL total CD4+ T cells
FVC relative change [ Time Frame: within 6 months after diagnosis ]
Relative change of FVC percentage

Original Primary Outcome Measures

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures

BAL antigen-specific Th1 and Th17 cells [ Time Frame: baseline (J0) ]
BAL antigen-specific Th1 and Th17 cells percentages among total BAL CD4+ T cells
FVC [ Time Frame: baseline (J0) ]
FVC percentage at ILD diagnosis
FVC absolute change [ Time Frame: within 6 months after diagnosis ]
Absolute change of FVC percentage
Global activity [ Time Frame: baseline (J0) ]
MDAAT score

Original Secondary Outcome Measures

Same as current

Current Other Pre-specified Outcome Measures

BAL ILC [ Time Frame: baseline (J0) ]
BAL ILC percentage among total BAL lymphoid cells
BAL MAIT [ Time Frame: baseline (J0) ]
BAL MAIT percentage among total BAL T cells

Original Other Pre-specified Outcome Measures

Same as current

Descriptive Information

Brief Title

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

Official Title

Evaluation of Antigen-specific Th1 and T17 Cells, ILC and MAIT in Patients With Antisynthetase Syndrome and Interstitial Lung Disease

Brief Summary

Antisynthetase syndrome (AS) is a rare overlapping myositis characterized by cellular and humoral autoimmune responses directed against aminoacyl-tRNA synthetases. Intesrtitial lung disease (ILD) is a leading cause of mortality in antisynthetase syndrome. Recently, antigen-specific IFN-γ+ CD4+ T cells have been identified in bronchoalveolar fluid (BAL) of patients with antisynthetase syndrome and ILD. Elevated levels of IL1β, IL12, IL18, TNFα, IL17A, IL22 have also been detected in peripheral blood of AS patients, especially those with progressive ILD. Implication of innate lymphoid cells (ILC) and mucosal-associated invariant T cells (MAIT) have not yet been studied in patients with AS. Targeted therapies against Th1 and Th17 cells may represent a promising treatment in patients AS patients with ILD.

Investigators suppose that antigen-specific Th1 and Th17 cells, ILC and MAIT at ILD diagnosis are associated with ILD severity at diagnosis and could predict treatment response at 6 months.

The main objective is to study the correlation between BAL antigen-specific Th1 and Th17 cells at ILD diagnosis and clinical evolution after 6 months of treatment according to initial ILD severity.

Detailed Description

Not Provided

Study Type

Observational

Study Design

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Patients with AS and ILD

Condition

Antisynthetase Syndrome

Intervention

Diagnostic Test: BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT

BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT

Study Groups/Cohorts

AS patients with ILD

New diagnosis of patients with AS syndrome and ILD

Intervention: Diagnostic Test: BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Not yet recruiting

Estimated Enrollment

Original Estimated Enrollment

Same as current

Estimated Study Completion Date

October 31, 2025

Estimated Primary Completion Date

October 31, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Patient with new diagnosis of AS with ILD

Exclusion Criteria:

Patient with ILD differential diagnosis
Corticosteroid treatment, immunosuppresive or immunomodulatory drugs in the past 3 months before diagnosis

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Not Provided

Contacts

Contact: Paul Decker, MD

+33383157240

p.decker@chru-nancy.fr

Listed Location Countries

France

Removed Location Countries

Administrative Information

NCT Number

NCT05984394

Other Study ID Numbers

2023-A00804-41

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement

Plan to Share IPD:

Current Responsible Party

Paul DECKER, MD, Central Hospital, Nancy, France

Original Responsible Party

Same as current

Current Study Sponsor

Central Hospital, Nancy, France

Original Study Sponsor

Same as current

Collaborators

Not Provided

Investigators

Principal Investigator:

Paul Decker, MD

CHU Nancy

PRS Account

Central Hospital, Nancy, France

Verification Date

August 2023

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