Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-29 @ 3:00 AM
Study NCT ID:
NCT01105468
Status:
TERMINATED
Last Update Posted:
2013-01-14
First Post:
2010-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breath Gas Analysis for the Diagnosis of Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'whyStopped': 'Sponsor quit partnership in Oncotyrol-Center for Personalized Medicine, and consequential loss of public funding.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-01-11', 'studyFirstSubmitDate': '2010-04-08', 'studyFirstSubmitQcDate': '2010-04-15', 'lastUpdatePostDateStruct': {'date': '2013-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breath gas markers', 'timeFrame': '3 years', 'description': 'Breath gas markers that allow to distinguish patients with mamma carcinoma from women without carcinoma;'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breath gas analysis', 'Volatile components in exhaled breath'], 'conditions': ['Mamma Carcinoma']}, 'descriptionModule': {'briefSummary': 'The volatile content of the exhaled breath gas of mamma carcinoma patients will be chemically analyzed by proton-transfer-reaction time of flight mass spectrometry.\n\nThe goal of the study is to determine typical breath gas components that allow to distinguish patients with mamma carcinoma from women without carcinoma. Further, the investigators will test whether these breath gas markers can be used as tumor markers, which change in a typical manner during the progress of the disease. Finally the data will be investigated for the presence of marker components, that identify patients who will develop metastasis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mamma carcinoma diagnosed by histology (cases)\n* Mamma carcinoma excluded by radiology (controls)\n* At the time of diagnosis before surgery\n* At the beginning and during chemotherapy;\n\nExclusion Criteria:\n\n* No informed consent form singed'}, 'identificationModule': {'nctId': 'NCT01105468', 'briefTitle': 'Breath Gas Analysis for the Diagnosis of Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ionimed Analytik GmbH'}, 'officialTitle': 'Leistungsbewertungsprüfung: Atemluftanalyse für Die Diagnose Von Brustkrebs, für Die Überwachung Der Therapie Und für Die Voraussage Des Metastasenrisikos', 'orgStudyIdInfo': {'id': 'BC1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mamma Carcinoma, no treatment', 'interventionNames': ['Device: Breath Collecting Unit']}, {'label': 'Mamma Carcinoma, treatment', 'interventionNames': ['Device: Breath Collecting Unit']}, {'label': 'No Mamma Carcinoma diagnosed by X-ray', 'interventionNames': ['Device: Breath Collecting Unit']}], 'interventions': [{'name': 'Breath Collecting Unit', 'type': 'DEVICE', 'otherNames': ['BCU'], 'description': 'Collect two breath gas samples per patient on one day before surgery', 'armGroupLabels': ['Mamma Carcinoma, no treatment', 'No Mamma Carcinoma diagnosed by X-ray']}, {'name': 'Breath Collecting Unit', 'type': 'DEVICE', 'otherNames': ['BCU'], 'description': 'Collect two or more breath gas samples on different days during adjuvant or neo-adjuvant therapy.', 'armGroupLabels': ['Mamma Carcinoma, treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'Department of Gynecology and Obstetrics, Medical University Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ionimed Analytik GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medical University Innsbruck', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}