Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-01-07 @ 11:45 PM
Study NCT ID:
NCT03271333
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2017-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Description of the Functional Evolution of Diffuse Infiltrating Pneumonia Associated With Systemic Scleroderma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}], 'ancestors': [{'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2017-08-31', 'studyFirstSubmitQcDate': '2017-08-31', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'composite criteria: forced vital capacity and CO diffusing capacity', 'timeFrame': 'At 24 months', 'description': 'Degradation of forced vital capacity (FVC) ≥10% and / or DLCO ≥15% of initial values at prospective follow-up at 24 months.'}], 'secondaryOutcomes': [{'measure': 'composite criteria: forced vital capacity and CO diffusing capacity', 'timeFrame': 'At 12 months', 'description': 'Degradation of forced vital capacity (FVC) ≥10% and / or DLCO ≥15% of initial values at prospective follow-up at 12 months.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Sclerosis']}, 'descriptionModule': {'briefSummary': 'Diffuse infiltrating pneumonia (DIP) is a severe complication of systemic sclerosis and one of the leading cause of death in this condition. The main objective of this study is to prospectively describe the evolution of DIP overtime and to find prognosis factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with systemic sclerosis and Diffuse Infiltrating Pneumonia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* systemic sclerosis\n* Diffuse Infiltrating Pneumonia\n\nExclusion Criteria:\n\n* infection\n* other lung diseases\n* non French native'}, 'identificationModule': {'nctId': 'NCT03271333', 'acronym': 'SCLERO-PID', 'briefTitle': 'Description of the Functional Evolution of Diffuse Infiltrating Pneumonia Associated With Systemic Scleroderma.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Description of the Functional Evolution of Diffuse Infiltrating Pneumonia Associated With Systemic Scleroderma and Analysis of Associated Factors.', 'orgStudyIdInfo': {'id': '2015_49'}, 'secondaryIdInfos': [{'id': '2016-A00722-49', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with systemic sclerosis', 'interventionNames': ['Other: lung function tests']}], 'interventions': [{'name': 'lung function tests', 'type': 'OTHER', 'description': 'Patients hospitalized realise a Resting pulmonary function tests (PFT) which include the assessment of ventilatory capacity: spirometry (forced expiratory flows and mobilisable volumes)', 'armGroupLabels': ['patients with systemic sclerosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Claude Huriez, CHU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '75571', 'city': 'Paris', 'country': 'France', 'facility': 'AH-HP, Hôpital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'David Launay, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}