Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 1:54 PM
Study NCT ID:
NCT03451994
Status:
COMPLETED
Last Update Posted:
2020-10-14
First Post:
2018-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory Study of Volatile Organic Compounds in Alveolar Breath
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-09-12', 'releaseDate': '2024-04-18'}], 'estimatedResultsFirstSubmitDate': '2024-04-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-13', 'studyFirstSubmitDate': '2018-02-18', 'studyFirstSubmitQcDate': '2018-02-25', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VOCs detected', 'timeFrame': '2 years', 'description': 'Expired air sample drawn principally from alveolar breath is analyzed by gas chromatography-mass spectrometry. Chromatograms are searched against the NIST library. The response for each analyte is normalized by using internal standards containing 1-bromo-4-fluoro-benzene.'}], 'secondaryOutcomes': [{'measure': 'Correlations between breath biomarkers and self-reported observations (questionnaires)', 'timeFrame': '1 year', 'description': 'VOC profiles will be compared with self-reported symptoms, observed exposures and other observations of participating subjects. Volatile organic compounds differentiating the disease activity will be identified.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nutritional and Metabolic Diseases']}, 'referencesModule': {'references': [{'pmid': '9177688', 'type': 'BACKGROUND', 'citation': 'Phillips M. Method for the collection and assay of volatile organic compounds in breath. Anal Biochem. 1997 May 1;247(2):272-8. doi: 10.1006/abio.1997.2069.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this secondary analysis is to identify breath signatures associated with idiopathic malodor conditions.', 'detailedDescription': 'Individuals with metabolic disorders may sporadically produce malodors despite good hygiene. Analysis of volatile organic compounds (VOCs) helps to gain insights into medical conditions arising due to metabolic dysfunction as different metabolic pathways emit and or consume various VOCs. These VOCs can be detected via the exhaled breath collected and analyzed with a portable breath collection apparatus. VOC profiles will be compared with self-reported symptoms and other observations of participating subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals self-reporting idiopathic malodor production as a consequence of a systemic disorder', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* good general health\n* willing and able to travel to one of the participating sites\n\nExclusion Criteria:\n\n* medical conditions that, in the opinion of the investigator, would prevent participation\n* elect not to participate in the study'}, 'identificationModule': {'nctId': 'NCT03451994', 'acronym': 'VOCs', 'briefTitle': 'Exploratory Study of Volatile Organic Compounds in Alveolar Breath', 'organization': {'class': 'OTHER', 'fullName': 'Mebo Research, Inc.'}, 'officialTitle': 'Retrospective Analysis of Volatile Organic Compounds in Alveolar Breath as Biomarkers of Idiopathic Malodor', 'orgStudyIdInfo': {'id': '20111001005MEBO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Body odor', 'description': 'individuals self-reporting idiopathic body odor with or without bad breath', 'interventionNames': ['Other: Breath test']}, {'label': 'Breath odor', 'description': 'individuals self-reporting idiopathic bad breath but no body odor', 'interventionNames': ['Other: Breath test']}], 'interventions': [{'name': 'Breath test', 'type': 'OTHER', 'otherNames': ['Exhaled breath metabolomics'], 'description': 'Breath samples taken from all participants, analyzed with gas chromatography mass spectrometry (GC/MS), no treatment given.', 'armGroupLabels': ['Body odor', 'Breath odor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'MeBO Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': 'W10 5LE', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'MeBO Research LTD', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Irene Gabashvili, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MeBO Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mebo Research, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Menssana Research, Inc.', 'class': 'INDUSTRY'}, {'name': 'Aurametrix', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-04-18', 'type': 'RELEASE'}, {'date': '2024-09-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mebo Research, Inc.'}}}}