Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-20 @ 4:46 PM
Study NCT ID:
NCT02781857
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-20
First Post:
2016-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mass Spectral Fingerprinting in Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 393}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2016-04-26', 'studyFirstSubmitQcDate': '2016-05-20', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of volatile organic compounds (VOCs) in the exhaled breath will be analysed using mass spectrometry', 'timeFrame': '1 day, single measurement', 'description': 'The primary outcome will be the lung cancer specific mass spectrometric profile of VOCs of exhaled breath analysis (markers of lung cancer in exhaled breath).'}], 'secondaryOutcomes': [{'measure': 'Group A: Concentration of volatile organic compounds (VOCs) in the exhaled breath will be analysed using mass spectrometry before and after lung cancer surgery', 'timeFrame': 'Group A: 2 measurements on 2 different days; Day 1: 1. measurement (before surgery), Day 2: (6-12 weeks after surgery): 2. measurement', 'description': 'The acquired profiles of mass spectral VOCs before and after lung cancer surgery will be analysed for significant differences.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Exhaled Breath', 'Mass Spectrometry', 'Fingerprinting'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '38718786', 'type': 'DERIVED', 'citation': 'Herth J, Schmidt F, Basler S, Sievi NA, Kohler M. Exhaled breath analysis in patients with potentially curative lung cancer undergoing surgery: a longitudinal study. J Breath Res. 2024 May 17;18(3). doi: 10.1088/1752-7163/ad48a9.'}]}, 'descriptionModule': {'briefSummary': 'To answer the question whether a disease specific profile of breath in patients with lung cancer can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with lung cancer will be included according to the predefined inclusion and exclusion criteria.\n\nMatched controls will be recruited from the general population by printed flyers, newspaper advertisements and personal communication.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed lung cancer based on cytological or histological analysis.\n* Group A: any type of lung cancer eligible for surgical resection (up to TNM stage IIIa).\n* Group B: any type of lung cancer (small-cell carcinoma, non-small-cell carcinoma) not amenable for surgical resection.\n* Group C: matched controls.\n* Age between 18 and 85 years at study entry\n\nExclusion Criteria:\n\n* Another 'active' secondary malignant disease (e.g. breast cancer, colon carcinoma) in group A and B, presence of any active malignant disease in group C (based on personal information).\n* Acute inflammatory disease (e.g. common cold) within the last 4 weeks.\n* Any other acute lung disease which affects breath measurements\n* Acute or chronic hepatic disease.\n* Renal failure or renal replacement therapy."}, 'identificationModule': {'nctId': 'NCT02781857', 'briefTitle': 'Mass Spectral Fingerprinting in Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS) in Patients With Lung Cancer', 'orgStudyIdInfo': {'id': 'KEK-ZH-Nr.2015-0607'}}, 'armsInterventionsModule': {'armGroups': [{'label': '100 patients with lung cancer', 'description': '* Group A: 70 patients with any type of lung cancer eligible for lung cancer surgery\n* Group B: 30 patients with any type of lung cancer not eligible to surgery (small-cell carcinoma, squamous cell carcinoma, adenocarcinoma, large-cell carcinoma).', 'interventionNames': ['Other: No intervention']}, {'label': '60 controls', 'description': '60 controls (group C) matched for age, gender, smoking history.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'armGroupLabels': ['100 patients with lung cancer', '60 controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Division of Pneumology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Malcolm Kohler, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swiss Federal Institute of Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}