Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-01-01 @ 8:43 PM
Study NCT ID:
NCT03284632
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2017-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
e-Cigarette - DNA Adducts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D000073865', 'term': 'Cigarette Smoking'}, {'id': 'D000072137', 'term': 'Vaping'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Buffy Coat, Serum, Plasma, Urine, Buccal Cells, Saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 217}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-08', 'studyFirstSubmitDate': '2017-09-13', 'studyFirstSubmitQcDate': '2017-09-13', 'lastUpdatePostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DNA Adducts', 'timeFrame': '6 months', 'description': 'Formation of Formaldehyde DNA Adducts in oral cells before and after smoking or vaping'}], 'secondaryOutcomes': [{'measure': 'Urinary 8-iso-PGF-2α', 'timeFrame': '6 months', 'description': 'Stability of Urinary 8-iso-PGF-2α (biomarkers of oxidative damage) over a 6-month sample period'}, {'measure': 'Urinary PGEM', 'timeFrame': '6 months', 'description': 'Stability of Urinary PGEM (biomarker of inflammation) over a 6-month sample period'}, {'measure': 'C-reactive protein', 'timeFrame': '6 months', 'description': 'Stability of C-reactive protein in serum (biomarker of inflammation) over a 6-month sample period'}, {'measure': 'TNE', 'timeFrame': '6 months', 'description': 'Total Nicotine Equivalents (nicotine exposure) over a 6-month sample period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tobacco', 'E-Cigarettes', 'Toxicants', 'Formaldehyde DNA Adducts', 'Oxidative Damage'], 'conditions': ['Smoking', 'Cigarette Smoking', 'Electronic Cigarettes']}, 'descriptionModule': {'briefSummary': 'This study will examine the level of toxicity of e-cigarette use compared to smokers and nonsmokers including inflammation markers, toxicant and carcinogen exposure. Additionally, the study will look at the effect of varying voltage levels for e-cigarette users.', 'detailedDescription': 'In this observational study, e-cigarette users, smokers, and non-users of e-cigarette or tobacco products (up to 134 per group) will be recruited from the Minneapolis-St. Paul area. This research will be conducted at the Tobacco Research Programs at the University of Minnesota. Subjects are screened for eligibility over the phone. If eligible after the phone screen, participants will be invited to attend orientation screening visit in the clinic where consent will be obtained and subjects will complete forms about their tobacco and e-cigarette use and medical history. Subjects who eligible will be asked to return for six visits over the course of six months.\n\nAt these appointments, subjects will provide biological specimen samples (buccal cells, urine and blood). Saliva will be collected before and after a smoking or vaping session. Non-users will only have 1 saliva collection.\n\nSubjects will be asked for information pertaining to and e-cigarette and tobacco use and overall health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be recruited locally within reasonable distance from the University of Minnesota.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good physical health with no unstable medical conditions; Able to provide written informed consent; Stable and good mental health;\n\nMeet criteria for 1 of three groups:\n\n1. Regular smokers confirmed by CO;\n2. E-cigarette users (exclusive e-cigarette use for 3 months); Non-Tobacco Users\n3. Non-smokers\n\nExclusion Criteria:\n\n* Unstable medical condition Not willing to attend visits'}, 'identificationModule': {'nctId': 'NCT03284632', 'briefTitle': 'e-Cigarette - DNA Adducts', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'e-Cigarettes: Formaldehyde DNA Adducts, Oxidative Damage, and Potential Toxicity and Carcinogenesis', 'orgStudyIdInfo': {'id': '2017NTLS040'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Smokers'}, {'label': 'E-cigarette users'}, {'label': 'Non-smokers'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55414', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Stephen Hecht, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}