Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT04016194
Status:
COMPLETED
Last Update Posted:
2019-07-11
First Post:
2019-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Survival in Children With Cystic Fibrosis Using the Multiple-breath Washout
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D003643', 'term': 'Death'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1990-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-09', 'studyFirstSubmitDate': '2019-05-07', 'studyFirstSubmitQcDate': '2019-07-09', 'lastUpdatePostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung clearance index (LCI)', 'timeFrame': 'Lung function is collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached', 'description': 'Lung function outcome derived by MBW and the compound Outcomes mortality or lung transplantation'}], 'secondaryOutcomes': [{'measure': 'Functional residual capacity (FRC)', 'timeFrame': 'Lung function is collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached', 'description': 'Lung function outcome derived by MBW'}, {'measure': 'Forced expired Volume in 1 second (FEV1)', 'timeFrame': 'Lung function is collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached', 'description': 'Lung function outcome derived by Spirometry'}, {'measure': 'Body weight', 'timeFrame': 'Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached', 'description': 'Anthropometric characteristics'}, {'measure': 'Body length', 'timeFrame': 'Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached', 'description': 'Anthropometric characteristics'}, {'measure': 'Gender', 'timeFrame': 'Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached', 'description': 'Anthropometric characteristics'}, {'measure': 'Presence of Pseudomonas aeruginosa infection', 'timeFrame': 'Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached', 'description': 'Clinical characteristics'}, {'measure': 'Presence of Staphylococcus aureus infection', 'timeFrame': 'Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached', 'description': 'Clinical characteristics'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple-breath washout, MBW', 'Lung clearance index, LCI', 'Prediction', 'Survival', 'Cystic Fibrosis, CF'], 'conditions': ['Cystic Fibrosis', 'Death', 'Lung Transplantation']}, 'referencesModule': {'references': [{'pmid': '34289977', 'type': 'DERIVED', 'citation': 'Kurz JM, Ramsey KA, Rodriguez R, Spycher B, Fischer Biner R, Latzin P, Singer F. Association of lung clearance index with survival in individuals with cystic fibrosis. Eur Respir J. 2022 Mar 3;59(3):2100432. doi: 10.1183/13993003.00432-2021. Print 2022 Mar.'}]}, 'descriptionModule': {'briefSummary': 'Retrospective cohort study using routinely collected annual data on lung clearance index (LCI) in combination with clinical data to predict survival in patients with Cystic Fibrosis. The primary study endpoint is the association of LCI with the compound outcome survival or lung transplantation in patients with CF.', 'detailedDescription': 'Retrospective analysis of longitudinal data collected during clinically routine from approximately 200 patients with CF aged 3 years or more between 01.01.1980 and 31.12.2005. The overall aim of this project is to retrospectively assess whether LCI measured for clinical purposes during school age is predictive for survival or lung transplantation in adulthood. For this, the investigators will assess in a systematic way clinically measured LCI and relate them with the compound outcome survival or lung transplantation retrospectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Non-Probability sample', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients treated at the Children's Hospital Bern\n* Confirmed CF Diagnosis\n* Age \\>= 3 years\n\nExclusion Criteria:\n\n* Uncertain diagnosis of CF according to current standards\n* Existing written or otherwise documented refusal to participate in research"}, 'identificationModule': {'nctId': 'NCT04016194', 'briefTitle': 'Prediction of Survival in Children With Cystic Fibrosis Using the Multiple-breath Washout', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Multiple-breath Washout for Lung Function Testing in Children With Cystic Fibrosis: Predictive for Survival?', 'orgStudyIdInfo': {'id': '3840'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lung function testing', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Multiple-breath washout, MBW'], 'description': 'Multiple-breath washout (MBW) is a safe, easy and sensitive lung function test using inert gases such as Nitrogen (N2) to assess efficiency of ventilation distribution. The latter can be estimated by the lung clearance index (LCI), an established study end-point in patients with CF'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3007', 'city': 'Bern', 'country': 'Switzerland', 'facility': "University Children's Hospital Bern", 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '3012', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Lindenhof Spital, Quartier Bleu', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Florian Singer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Insel Gruppe AG, University Hospital Bern'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Until 12/2020', 'ipdSharing': 'YES', 'description': 'IPD will be shared with researchers involved in the data collection and analysis.', 'accessCriteria': 'Researchers involved in data collection'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lindenhofspital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}