Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-23 @ 6:29 AM
Study NCT ID:
NCT02564393
Status:
COMPLETED
Last Update Posted:
2015-09-30
First Post:
2015-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Induction of Neutrophilic Traps ( NETs ) by the Environment and Infectious Inflammatory Lung Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'lastUpdateSubmitDate': '2015-09-29', 'studyFirstSubmitDate': '2015-09-29', 'studyFirstSubmitQcDate': '2015-09-29', 'lastUpdatePostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the DNA concentration secreted into the extracellular environment neutrophil activated', 'timeFrame': '1 hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'The study is defined in 3 stages of in vitro assays :\n\nPhase 1 : Secretion of NETs in response to lung disease and their secretion of factors.\n\nThis is a transversal study in which we compare :\n\n* Producing NETs (DNA and proteases ) by neutrophils purified from sputum and blood of patients\n* Producing NETs (DNA and proteases ) by purified neutrophils in the blood of patients and blood of control subjects\n\nPhase 2: Mechanisms of activation of NETs secretory pathways . This phase will identify receptors (TLR ) involved in the secretion of NETs and analyze the involvement of dependent transduction pathways calcium and PKC . It will be performed on control blood neutrophils.\n\nPhase 3: Analysis of cell death ( NETose )\n\nThis is a transversal study that will analyze :\n\nthe mode of cell death of neutrophils purified blood and sputum of patients and control blood neutrophils by flow cytometry and transmission electron microscopy .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pathophysiological study comparing a " Cystic fibrosis " group to a control group (adults)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients :\n\n* Men or women over 18\n* Patients with mucoviscidose in stable condition, i.e. not having presented an acute push of bronchopulmonary attack requiring a antibiothérapie or a hospitalization for treatment of its disease during the 2 previous weeks\n* Signed consent\n\nVolunteers :\n\n* Men or women over 18\n* Without respiratory antecedent nor known respiratory pathology\n* Signed consent\n\nExclusion Criteria:\n\nPatients :\n\n* In exclusion period of an other study\n\nVolunteers :\n\n* In exclusion period of an other study\n* Antibiotic treatment and/or anti-inflammatory drug (AINS or corticoids) in the 2 weeks before inclusion in the study'}, 'identificationModule': {'nctId': 'NCT02564393', 'acronym': 'MucoNETs', 'briefTitle': 'Induction of Neutrophilic Traps ( NETs ) by the Environment and Infectious Inflammatory Lung Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Secretion Induction of Neutrophil Extracellular Traps (NETs)in Inflammatory and Infectious Environment of Mucoviscidose', 'orgStudyIdInfo': {'id': 'PHAO09-PD / MucoNETs'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'T', 'description': 'Control'}, {'label': 'A', 'description': 'Adult with cystic fibrosis'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tours', 'country': 'France', 'facility': 'CHRU de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}