Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:12 PM
Study NCT ID:
NCT05810493
Status:
RECRUITING
Last Update Posted:
2023-05-10
First Post:
2023-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Cohort of Patients With Phenotyped Diffuse Interstitial Lung Disease With Longitudinal Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2023-03-29', 'studyFirstSubmitQcDate': '2023-04-11', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Build a retrospective cohort of patients with phenotyped interstitial Lung disease with longitudinal follow-up', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Follow-up of progression criteria according to diagnosis', 'timeFrame': '2 years', 'description': 'Change in pulmonary functional tests'}, {'measure': 'Follow-up of progression criteria according to diagnosis', 'timeFrame': '2 years', 'description': 'Change in respiratory symptoms'}, {'measure': 'Follow-up of progression criteria according to diagnosis', 'timeFrame': '2 years', 'description': 'Change in High-resolution Computed Tomography (HRCT) images'}, {'measure': 'Follow-up of progression criteria according to diagnosis', 'timeFrame': '2 years', 'description': 'Impact of interstitial lung disease treatements'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Interstitial Lung Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to conduct a descriptive analysis of the population of patients with an interstitial lung disease received in the pulmonary department of University hospital of Nice (France). Analysis and documentation of clinical forms of the disease, therapeutics used and evolutions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '≥ 18 years old; Patients with a formal diagnosis or a provisional diagnosis of interstitial lung disease according to the mutlidisciplinary monthly meeting for interstitial lung disease occuring at University hospital of Nice, France', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Diagnosis of interstitial lung disease according to the multidisciplinary monthly meeting for interstitial lung disease occuring at University hospital of Nice, France\n\nExclusion Criteria:\n\n* Patient-led opposition to data collection'}, 'identificationModule': {'nctId': 'NCT05810493', 'briefTitle': 'A Cohort of Patients With Phenotyped Diffuse Interstitial Lung Disease With Longitudinal Follow-up', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'A Cohort of Patients With Phenotyped Diffuse Interstitial Lung Disease With Longitudinal Follow-up', 'orgStudyIdInfo': {'id': '23Pneumo01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'Follow-up of disease, therapeutics and evolution'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06200', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sylvie LEROY', 'role': 'CONTACT', 'email': 'leroy.s2@chu-nice.fr', 'phone': '+33492038580'}], 'facility': 'University Hospital of Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Sylvie LEROY, MD, PhD', 'role': 'CONTACT', 'email': 'leroy.s2@chu-nice.fr', 'phone': '+33 4 92 03 85 80'}, {'name': 'ARC Pneumologie', 'role': 'CONTACT', 'email': 'ARCSpneumologie@chu-nice.fr', 'phone': '+33 4 92 03 82 81'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}