Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-03 @ 7:43 AM
Study NCT ID:
NCT02595632
Status:
COMPLETED
Last Update Posted:
2020-10-05
First Post:
2015-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breath Analysis in Healthy Controls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-01', 'studyFirstSubmitDate': '2015-11-02', 'studyFirstSubmitQcDate': '2015-11-02', 'lastUpdatePostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome will be the mass spectrometric exhaled breath pattern of healthy subjects.', 'timeFrame': '1 day, single measurement, no follow up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Exhaled Breath', 'Mass Spectrometry', 'Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to detect a specific profile of breath in healthy subjects by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy subjects will be included according to the predefined inclusion and exclusion criteria. They will be recruited from the general population by printed flyers, newspaper advertisements and personal communication.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Normal spirometry (forced expiratory volume in 1 second (FEV1) \\> 80%, forced vital capacity (FVC) \\> 80%, FEV1/FVC \\> 70%.).\n2. Age between 18 and 90 years at study entry.\n\nExclusion Criteria:\n\n1. Presence of an active malignancy.\n2. Presence of any lung disease (e.g. asthma, chronic obstructive pulmonary disease (COPD), sarcoidosis)\n3. Acute inflammatory disease (e.g. common cold) within the last 6 weeks.\n4. Acute or chronic hepatic disease.\n5. Renal failure or renal replacement therapy.'}, 'identificationModule': {'nctId': 'NCT02595632', 'briefTitle': 'Breath Analysis in Healthy Controls', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Exhaled Breath Analysis by Secondary Electrospray Ionization (SESI-MS) in Healthy Controls', 'orgStudyIdInfo': {'id': 'KEK-ZH-Nr. 2015-0187'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy', 'description': 'Healthy subjects with no apparent lung disease and normal lung function testing.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'armGroupLabels': ['Healthy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Pulmonary Division', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swiss Federal Institute of Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}