Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 11:04 PM
Study NCT ID:
NCT05726994
Status:
UNKNOWN
Last Update Posted:
2023-03-22
First Post:
2023-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Volatilomic Approaches for the Study of CFTR Modulators (VOLATIL-CF)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Induced sputum, Plasma, Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-20', 'studyFirstSubmitDate': '2023-01-12', 'studyFirstSubmitQcDate': '2023-02-03', 'lastUpdatePostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'volatile organic compounds (VOC) profile', 'timeFrame': 'At 0 day, 7 days, and 1 month of treatment', 'description': 'identification of VOCs in exhaled breath with a significant variation between 0 day, 7 days, and/or 1 month of treatment'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'At 0 day, 7 days, and 1 month of treatment', 'description': 'Weight measured at visits'}, {'measure': 'Sweat test', 'timeFrame': 'At 0 day, 7 days, and 1 month of treatment', 'description': 'Sweat test result'}, {'measure': 'Induced sputum - microbiology', 'timeFrame': 'At 0 day, 7 days, and 1 month of treatment', 'description': 'Results of microbiological analysis of induced sputum'}, {'measure': 'Induced sputum - immunology', 'timeFrame': 'At 0 day, 7 days, and 1 month of treatment', 'description': 'Results of inflammatory markers analysis of induced sputum (neutrophil elastase, IL-8, IL-1b, IL-6)'}, {'measure': 'Spirometry', 'timeFrame': 'At 0 day, 7 days, and 1 month of treatment', 'description': 'Results of spirometry FVC measurements'}, {'measure': 'Spirometry', 'timeFrame': 'At 0 day, 7 days, and 1 month of treatment', 'description': 'Results of spirometry FEV1 measurements'}, {'measure': 'Spirometry', 'timeFrame': 'At 0 day, 7 days, and 1 month of treatment', 'description': 'Results of spirometry DEM25-75 measurements'}, {'measure': 'Urine', 'timeFrame': 'At 0 day and 1 month of treatment', 'description': 'Biobanking for metabolic study'}, {'measure': 'Blood', 'timeFrame': 'At 0 day and 1 month of treatment', 'description': 'Biobanking for metabolic study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cystic Fibrosis', 'volatile organic compounds (VOC)', 'exhaled breath', 'CFTR modulators'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': "This study relies on the hypotheses that (1) exhaled breath is intimately correlated to the patient's lung condition and that (2)the composition of exhaled breath , i.e. the VOCs profile, will be significantly modified from the first days of treatment by CFTR modulators in a or pauci/symptomatic patients such as young children under 12 years old. The non-invasive and longitudinal collection and analysis of exhaled breath may reveal modifications in signaling pathways impacted by these treatments on the very short term. This study is a single-center pilot study.", 'detailedDescription': 'This is a single-center prospective cohort study that plans to include 20 children with cystic fibrosis aged 6 to 12 years old who will initiate Kaftrio® in early 2023.\n\nThe children will be monitored for one month; three visits are planned as part of routine care (before initiation of treatment, in the course of the first week and after one month of treatment) during which exhaled breath collection and analysis will also be performed. Access to clinical data collected throughout routine follow-up of these children (analysis of induced sputum, urine and blood, sweat test, respiratory function tests) will be granted upon patient/parent authorization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with cystic fibrosis aged 6 to 12 who will start Kaftrio® treatment.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with cystic fibrosis initiating Kaftrio® treatment.\n* Patients and holders of parental authority not opposing participation in this research.\n* Patients affiliated to a Health Insurance system or beneficiaries. Exclusion Criteria\n* Patients deprived of liberty or under guardianship.\n* Pregnant or breastfeeding patients.\n* Lung transplanted patients.'}, 'identificationModule': {'nctId': 'NCT05726994', 'acronym': 'VOLATIL-CF', 'briefTitle': 'Volatilomic Approaches for the Study of CFTR Modulators (VOLATIL-CF)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Volatilomic Approaches for the Study of CFTR Modulators', 'orgStudyIdInfo': {'id': 'APHP221173'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cystic fibrosis and Kaftrio®', 'description': '20 children with cystic fibrosis aged 6 to 12 who initiate Kaftrio®', 'interventionNames': ['Biological: exhaled breath collection', 'Other: Data collection']}], 'interventions': [{'name': 'exhaled breath collection', 'type': 'BIOLOGICAL', 'description': 'Fasting children will be asked to breathe normally through a mouthpiece for the collection and analysis of exhaled breath.', 'armGroupLabels': ['cystic fibrosis and Kaftrio®']}, {'name': 'Data collection', 'type': 'OTHER', 'description': 'Clinical data will be collected in order to seek correlations with the exhaled breath profile.', 'armGroupLabels': ['cystic fibrosis and Kaftrio®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charlote ROY, Doctor', 'role': 'CONTACT', 'email': 'charlotte.roy@aphp.fr', 'phone': '01 44 49 44 92'}], 'facility': 'Hôpital Necker - Enfants malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Charlotte ROY, Doctor', 'role': 'CONTACT', 'email': 'charlotte.roy@aphp.fr', 'phone': '+33 1 44 49 44 92'}, {'name': 'Laure CHOUPEAUX, MSc', 'role': 'CONTACT', 'email': 'laure.choupeaux@aphp.fr', 'phone': '+33 1 44 38 17 11'}], 'overallOfficials': [{'name': 'Isabelle SERMET-GAUDELUS, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'APHP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}