Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2026-02-06 @ 10:32 AM
Study NCT ID:
NCT02924818
Status:
RECRUITING
Last Update Posted:
2025-02-24
First Post:
2016-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D016626', 'term': 'Shadowing Technique, Histology'}, {'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013194', 'term': 'Staining and Labeling'}, {'id': 'D016591', 'term': 'Histocytological Preparation Techniques'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 225}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2036-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2016-10-04', 'studyFirstSubmitQcDate': '2016-10-04', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Specific measurements: cytokines (Th1, Th2, Th17, Tc1, Tc2, Tc17) measurements in blood sample', 'timeFrame': 'baseline'}, {'measure': 'Specific measurements: cytokines (Th1, Th2, Th17, Tc1, Tc2, Tc17) measurements in blood sample', 'timeFrame': 'up to 10 years'}]}, 'conditionsModule': {'conditions': ['Chronic Inflammatory Pulmonary Diseases']}, 'referencesModule': {'references': [{'pmid': '37990322', 'type': 'DERIVED', 'citation': 'Charon L, Launois C, Perotin JM, Ravoninjatovo B, Mulette P, Ancel J, Guillard T, Muggeo A, Dormoy V, Griffon M, Carre S, Lebargy F, Deslee G, Dury S. Current cough and sputum assessed by the cough and sputum assessment-questionnaire (CASA-Q) is associated with quality of life impairment in cystic fibrosis. BMC Pulm Med. 2023 Nov 21;23(1):457. doi: 10.1186/s12890-023-02701-3.'}, {'pmid': '34404378', 'type': 'DERIVED', 'citation': 'Dury S, Perotin JM, Ravoninjatovo B, Llerena C, Ancel J, Mulette P, Griffon M, Carre S, Perrin A, Lebargy F, Deslee G, Launois C. Identifying specific needs in adult cystic fibrosis patients: a pilot study using a custom questionnaire. BMC Pulm Med. 2021 Aug 18;21(1):270. doi: 10.1186/s12890-021-01613-4.'}, {'pmid': '33794842', 'type': 'DERIVED', 'citation': 'Mulette P, Ravoninjatovo B, Guguen C, Barbe C, Ancel J, Dury S, Dumazet A, Perdu D, Perotin JM, Guillard T, Lebargy F, Deslee G, Launois C. Insomnia in adults with cystic fibrosis: strong association with anxiety/depression and impaired quality of life. BMC Pulm Med. 2021 Apr 1;21(1):108. doi: 10.1186/s12890-021-01473-y.'}]}, 'descriptionModule': {'briefSummary': 'Chronic inflammatory pulmonary diseases including chronic obstructive pulmonary disease (COPD), interstitial lung diseases (ILD), bronchiectasis, and cystic fibrosis (CF) are characterized by lung inflammation and remodelling. Clinical, functional, microbiological, biological, pathological and prognosis features are highly variable and heterogeneous. A precise phenotyping is a key-element to better understanding the pathophysiology of these chronic inflammatory diseases and to develop innovative treatment strategies.\n\nThe objectives of this prospective study is to analyze the clinical, demographic, biological, morphological, pathological, and microbiological characteristics in a cohort of patients diagnosed with COPD, ILD, bronchiectasis, and CF. The associations between clinical, demographic, biological, morphological, pathological, and microbiological features will be assessed.\n\nThe Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases (the RINNOPARI Project: Recherche et Innovation en Pathologie Respiratoire Inflammatoire) is a monocentric study conducted at the University Hospital of Reims, France. Adult patients (\\>18 year-old) followed at the University Hospital of Reims and diagnosed with COPD, ILD, bronchiectasis, or CF will be considered for inclusion. Patients will sign an informed consent for inclusion. Exclusion criteria include "subjects protected by the law" as required by the French authorities. Control patients with no respiratory diseases after clinical and pulmonary function tests assessment will be also included. The expected number of patients included is 225 (COPD, n=100; CF, n=25; bronchiectasis, n=25; ILD, n=25; controls, n=50). Inclusion will be conducted for 36 months from September 2016 (9/30/2016) to September 2019 (9/30/2019).\n\nFor all COPD, ILD, bronchiectasis, and CF patients included, data will be registered at inclusion, and at follow-up visits for 10 years. Patients will be followed-up as usual care with no specific therapeutic intervention. For control patients, data will be registered at inclusion with no follow-up.\n\nData will be registered in a centralized anonymized database. The characteristics of the patients will be described as mean and standard deviation for quantitative data and as number and percentages for qualitative data. Comparisons and associations between groups and variables will be analyzed by Student, Wilcoxon, Chi2, Fischer exact, and Spearman tests as applicable. A p\\<0.05 will be considered as significant.\n\nThis study should help to better characterize clinical, demographic, biological, morphological, pathological, and microbiological characteristics and phenotypes in chronic inflammatory respiratory diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (\\>18 year-old) with COPD, CF, bronchiectasis or ILD\n\nExclusion Criteria:\n\n* \\<18 year-old'}, 'identificationModule': {'nctId': 'NCT02924818', 'acronym': 'RINNOPARI', 'briefTitle': 'Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Reims'}, 'officialTitle': 'Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases: The RINNOPARI Project', 'orgStudyIdInfo': {'id': 'PO16020*'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chronic Obstructive Pulmonary disease (COPD)', 'interventionNames': ['Other: Clinical assessment', 'Behavioral: questionnaires', 'Other: pulmonary function test', 'Biological: blood test', 'Biological: microbiology', 'Biological: histology', 'Other: imaging']}, {'type': 'EXPERIMENTAL', 'label': 'Cystic Fibrosis (CF)', 'interventionNames': ['Other: Clinical assessment', 'Behavioral: questionnaires', 'Other: pulmonary function test', 'Biological: blood test', 'Biological: microbiology', 'Biological: histology', 'Other: imaging']}, {'type': 'EXPERIMENTAL', 'label': 'bronchiectasis', 'interventionNames': ['Other: Clinical assessment', 'Behavioral: questionnaires', 'Other: pulmonary function test', 'Biological: blood test', 'Biological: microbiology', 'Biological: histology', 'Other: imaging']}, {'type': 'EXPERIMENTAL', 'label': 'Interstitial lung disease (ILD)', 'interventionNames': ['Other: Clinical assessment', 'Behavioral: questionnaires', 'Other: pulmonary function test', 'Biological: blood test', 'Biological: microbiology', 'Biological: histology', 'Other: imaging']}, {'type': 'EXPERIMENTAL', 'label': 'controls', 'interventionNames': ['Other: Clinical assessment', 'Behavioral: questionnaires', 'Other: pulmonary function test', 'Biological: blood test', 'Biological: microbiology', 'Biological: histology', 'Other: imaging']}], 'interventions': [{'name': 'Clinical assessment', 'type': 'OTHER', 'armGroupLabels': ['Chronic Obstructive Pulmonary disease (COPD)', 'Cystic Fibrosis (CF)', 'Interstitial lung disease (ILD)', 'bronchiectasis', 'controls']}, {'name': 'questionnaires', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Chronic Obstructive Pulmonary disease (COPD)', 'Cystic Fibrosis (CF)', 'Interstitial lung disease (ILD)', 'bronchiectasis', 'controls']}, {'name': 'pulmonary function test', 'type': 'OTHER', 'armGroupLabels': ['Chronic Obstructive Pulmonary disease (COPD)', 'Cystic Fibrosis (CF)', 'Interstitial lung disease (ILD)', 'bronchiectasis', 'controls']}, {'name': 'blood test', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Chronic Obstructive Pulmonary disease (COPD)', 'Cystic Fibrosis (CF)', 'Interstitial lung disease (ILD)', 'bronchiectasis', 'controls']}, {'name': 'microbiology', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Chronic Obstructive Pulmonary disease (COPD)', 'Cystic Fibrosis (CF)', 'Interstitial lung disease (ILD)', 'bronchiectasis', 'controls']}, {'name': 'histology', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Chronic Obstructive Pulmonary disease (COPD)', 'Cystic Fibrosis (CF)', 'Interstitial lung disease (ILD)', 'bronchiectasis', 'controls']}, {'name': 'imaging', 'type': 'OTHER', 'armGroupLabels': ['Chronic Obstructive Pulmonary disease (COPD)', 'Cystic Fibrosis (CF)', 'Interstitial lung disease (ILD)', 'bronchiectasis', 'controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51092', 'city': 'Reims', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Damien JOLLY', 'role': 'CONTACT', 'email': 'djolly@chu-reims.fr', 'phone': '326788472', 'phoneExt': '33'}], 'facility': 'Chu Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}], 'centralContacts': [{'name': 'Gaëtan Deslée', 'role': 'CONTACT', 'email': 'gdeslee@chu-reims.fr', 'phone': '326787611', 'phoneExt': '33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Reims', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}