Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT05458934
Status:
RECRUITING
Last Update Posted:
2024-08-15
First Post:
2022-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Exhaled Breath From Patients With Lung-/Airway Diseases (BigExBrESs)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2022-06-30', 'studyFirstSubmitQcDate': '2022-07-13', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Molecular breath pattern', 'timeFrame': 'at baseline', 'description': 'Comparison of molecular weights of breath features from patients with different respiratory diseases'}], 'secondaryOutcomes': [{'measure': 'Change in molecular breath pattern', 'timeFrame': 'over one year', 'description': 'Change in the molecular breath pattern during the course of the disease (untargeted approach)'}, {'measure': 'Symptoms', 'timeFrame': 'at baseline', 'description': 'Correlation/Association of molecular weights of specific breath features with symptoms (e.g. dyspnea)'}, {'measure': 'Inflammatory markers', 'timeFrame': 'at baseline', 'description': 'Correlation/Association of molecular weights of specific breath features with inflammatory markers (e.g. eosinophils)'}, {'measure': 'Controls', 'timeFrame': 'at baseline', 'description': 'Differentiation of molecular breath pattern (m/z ratios of molecules in exhaled breath) between diseased patients and participants without respiratory disease (untargeted approach)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung-/Airway Diseases']}, 'referencesModule': {'references': [{'pmid': '40474893', 'type': 'DERIVED', 'citation': 'Basler S, Fricke K, Sievi NA, Arvaji A, Schmidt F, Herth J, Baur DM, Kohler M, Ulrich S, Lichtblau M. Exploring breath metabolomics as a non-invasive tool for detecting pulmonary vascular disease. Eur Heart J Open. 2025 May 23;5(3):oeaf060. doi: 10.1093/ehjopen/oeaf060. eCollection 2025 May.'}]}, 'descriptionModule': {'briefSummary': 'Ananlyis of exhaled breath of patients with lung-/airway diseases to identify and distinguish respiratory diseases, and improve the disease manangament.', 'detailedDescription': 'Breath analysis offers a unique opportunity to non-invasively retrieve unlimited samples of relevant information on the ongoing internal biochemical processes, as parts of the most volatile components in blood reach the gas phase and are subsequently exhaled (e.g. detection of ethanol in breath). Analysis of exhaled breath provides biochemical information about the metabolism and the pathophysiological state. Chemical analysis of exhaled breath with mass spectrometry identified numerous volatile organic compounds (VOCs) \\[low molecular weightcomponents:\\< 500 Dalton (Da)\\]. Using Big Data analytics, specific patterns of diverse respiratory disease (e.g. for COPD and asthma) can be identified and the different diseases can be distinguished from each other. Specific Big Data Analytics might also improve the management of disease (e.g.avoiding of exacerbations) by identifying early signs of exacerbation risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'General population', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Age ≥ 18 years at study entry\n\nExclusion Criteria:\n\n* Physical or intellectual impairment precluding informed consent or protocol adherence\n* Known pregnancy'}, 'identificationModule': {'nctId': 'NCT05458934', 'acronym': 'BigExBrESs', 'briefTitle': 'Analysis of Exhaled Breath From Patients With Lung-/Airway Diseases (BigExBrESs)', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Analysis of Exhaled Breath From Patients With Lung-/Airway Diseases (BigExBrESs)', 'orgStudyIdInfo': {'id': '2021-00539'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lung-/Airway diseases', 'description': 'Patients with lung-/airway diseases', 'interventionNames': ['Other: No intervention']}, {'label': 'Controls', 'description': 'Participants without lung-/airway disease', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['Controls', 'Lung-/Airway diseases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Malcolm Kohler, MD', 'role': 'CONTACT', 'email': 'malcolm.kohler@usz.ch', 'phone': '+41442551111'}, {'name': 'Noriane Sievi, MSc', 'role': 'CONTACT', 'email': 'noriane.sievi@usz.ch', 'phone': '+41442559815'}], 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Malcolm Kohler, MD', 'role': 'CONTACT', 'email': 'malcolm.kohler@usz.ch', 'phone': '+41442551111'}, {'name': 'Noriane Sievi, MSc', 'role': 'CONTACT', 'email': 'noriane.sievi@usz.ch', 'phone': '+41442559815'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'if requested'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Deep Breath Intelligence (DBI)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}