Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 11:04 PM
Study NCT ID:
NCT05984394
Status:
RECRUITING
Last Update Posted:
2024-08-27
First Post:
2023-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Antigen-specific T Cells in Patients With Antisynthetase Syndrome and Interstitial Lung Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537778', 'term': 'Antisynthetase syndrome'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-26', 'studyFirstSubmitDate': '2023-08-02', 'studyFirstSubmitQcDate': '2023-08-02', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'BAL ILC', 'timeFrame': 'baseline (J0)', 'description': 'BAL ILC percentage among total BAL lymphoid cells'}, {'measure': 'BAL MAIT', 'timeFrame': 'baseline (J0)', 'description': 'BAL MAIT percentage among total BAL T cells'}], 'primaryOutcomes': [{'measure': 'BAL antigen-specific Th1 and Th17 cells', 'timeFrame': 'baseline (J0)', 'description': 'BAL antigen-specific Th1 and Th17 cells percentages among BAL total CD4+ T cells'}, {'measure': 'FVC relative change', 'timeFrame': 'within 6 months after diagnosis', 'description': 'Relative change of FVC percentage'}], 'secondaryOutcomes': [{'measure': 'BAL antigen-specific Th1 and Th17 cells', 'timeFrame': 'baseline (J0)', 'description': 'BAL antigen-specific Th1 and Th17 cells percentages among total BAL CD4+ T cells'}, {'measure': 'FVC', 'timeFrame': 'baseline (J0)', 'description': 'FVC percentage at ILD diagnosis'}, {'measure': 'FVC absolute change', 'timeFrame': 'within 6 months after diagnosis', 'description': 'Absolute change of FVC percentage'}, {'measure': 'Global activity', 'timeFrame': 'baseline (J0)', 'description': 'MDAAT score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Antisynthetase Syndrome']}, 'descriptionModule': {'briefSummary': '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.\n\nInvestigators 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with AS and ILD', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with new diagnosis of AS with ILD\n\nExclusion Criteria:\n\n* Patient with ILD differential diagnosis\n* Corticosteroid treatment, immunosuppresive or immunomodulatory drugs in the past 3 months before diagnosis'}, 'identificationModule': {'nctId': 'NCT05984394', 'acronym': 'CYTILDASS', 'briefTitle': 'Evaluation of Antigen-specific T Cells in Patients With Antisynthetase Syndrome and Interstitial Lung Disease', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Evaluation of Antigen-specific Th1 and T17 Cells, ILC and MAIT in Patients With Antisynthetase Syndrome and Interstitial Lung Disease', 'orgStudyIdInfo': {'id': '2023-A00804-41'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AS patients with ILD', 'description': 'New diagnosis of patients with AS syndrome and ILD', 'interventionNames': ['Diagnostic Test: BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT']}], 'interventions': [{'name': 'BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT', 'type': 'DIAGNOSTIC_TEST', 'description': 'BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT', 'armGroupLabels': ['AS patients with ILD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bernard Bonnotte, PhD', 'role': 'CONTACT'}], 'facility': 'Bernard Bonnotte', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Metz', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julien Campagne, MD', 'role': 'CONTACT'}], 'facility': 'Julien Campagne', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Paul Decker', 'role': 'CONTACT', 'email': 'p.decker@chru-nancy.fr', 'phone': '+33383157240'}], 'facility': 'Paul Decker', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Oivier Benveniste, PhD', 'role': 'CONTACT'}], 'facility': 'Olivier Benveniste', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Reims', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Loïs Bolko, MD', 'role': 'CONTACT'}], 'facility': 'Loïs Bolko', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alain Meyer, PhD', 'role': 'CONTACT'}], 'facility': 'Alain Meyer', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Paul Decker, MD', 'role': 'CONTACT', 'email': 'p.decker@chru-nancy.fr', 'phone': '+33383157240'}], 'overallOfficials': [{'name': 'Paul Decker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU NANCY'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Paul DECKER, MD', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}