Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2026-01-06 @ 8:50 PM
Study NCT ID:
NCT03285893
Status:
COMPLETED
Last Update Posted:
2024-11-12
First Post:
2017-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oral Cell DNA Adducts in Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jense010@umn.edu', 'phone': '612-624-5178', 'title': 'Joni Jensen', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'No adverse events collected, single visit observational study', 'eventGroups': [{'id': 'EG000', 'title': 'Native Hawaiian Cigarette Smokers', 'description': 'oral cell DNA adducts\n\noral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'White (European Americans) Cigarette Smokers', 'description': 'oral cell DNA adducts\n\noral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Japanese American Cigarette Smokers', 'description': 'oral cell DNA adducts\n\noral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Concentration of γ-OH-Acr-dGuo, a Major Acrolein-DNA Adduct', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Native Hawaiian Cigarette Smokers', 'description': 'oral cell DNA adducts\n\noral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts'}, {'id': 'OG001', 'title': 'White (European Americans) Cigarette Smokers', 'description': 'oral cell DNA adducts\n\noral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts'}, {'id': 'OG002', 'title': 'Japanese American Cigarette Smokers', 'description': 'oral cell DNA adducts\n\noral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts'}], 'classes': [{'categories': [{'measurements': [{'value': '49.7', 'groupId': 'OG000', 'lowerLimit': '41.2', 'upperLimit': '59.9'}, {'value': '67.1', 'groupId': 'OG001', 'lowerLimit': '55.7', 'upperLimit': '80.7'}, {'value': '46.5', 'groupId': 'OG002', 'lowerLimit': '37.2', 'upperLimit': '58.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Acrolein-DNA adduct (8R/S)-3-(2'-deoxyribos-1'-yl)-5,6,7,8-tetrahy- dro-8-hydroxypyrimido\\[1,2-a\\]purine-10(3H)-one. Model adjusted for age, sex and race/ethnicity", 'unitOfMeasure': '10^9 nucleotides/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'εdAdo, Per 10^9 Nucleotides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Native Hawaiian Cigarette Smokers', 'description': 'oral cell DNA adducts\n\noral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts'}, {'id': 'OG001', 'title': 'White (European Americans) Cigarette Smokers', 'description': 'oral cell DNA adducts\n\noral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts'}, {'id': 'OG002', 'title': 'Japanese American Cigarette Smokers', 'description': 'oral cell DNA adducts\n\noral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts'}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000', 'lowerLimit': '9.9', 'upperLimit': '12.9'}, {'value': '11.3', 'groupId': 'OG001', 'lowerLimit': '9.94', 'upperLimit': '12.9'}, {'value': '9.16', 'groupId': 'OG002', 'lowerLimit': '7.83', 'upperLimit': '10.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Lipid peroxidation-related adduct 1,N6-etheno-dAdo etheno-DNA adducts from peroxidation of lipids. Model adjusted for age, sex and race/ethnicity', 'unitOfMeasure': '10^9 nucleotides/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Native Hawaiian Cigarette Smokers', 'description': 'oral cell DNA adducts\n\noral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts'}, {'id': 'FG001', 'title': 'White (European Americans) Cigarette Smokers', 'description': 'oral cell DNA adducts\n\noral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts'}, {'id': 'FG002', 'title': 'Japanese American Cigarette Smokers', 'description': 'oral cell DNA adducts\n\noral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '101'}, {'groupId': 'FG002', 'numSubjects': '79'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '101'}, {'groupId': 'FG002', 'numSubjects': '79'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '281', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Native Hawaiian Cigarette Smokers', 'description': 'oral cell DNA adducts\n\noral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts'}, {'id': 'BG001', 'title': 'White (European Americans) Cigarette Smokers', 'description': 'oral cell DNA adducts\n\noral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts'}, {'id': 'BG002', 'title': 'Japanese American Cigarette Smokers', 'description': 'oral cell DNA adducts\n\noral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'spread': '17.7', 'groupId': 'BG000'}, {'value': '47.5', 'spread': '15.7', 'groupId': 'BG001'}, {'value': '59.2', 'spread': '14.6', 'groupId': 'BG002'}, {'value': '50.1', 'spread': '16.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-02', 'size': 532676, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-12-07T12:20', 'hasProtocol': True}, {'date': '2020-10-05', 'size': 251244, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-12-07T12:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'oral cell DNA and urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 281}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2017-09-01', 'resultsFirstSubmitDate': '2023-12-07', 'studyFirstSubmitQcDate': '2017-09-14', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-05', 'studyFirstPostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of γ-OH-Acr-dGuo, a Major Acrolein-DNA Adduct', 'timeFrame': 'Baseline', 'description': "Acrolein-DNA adduct (8R/S)-3-(2'-deoxyribos-1'-yl)-5,6,7,8-tetrahy- dro-8-hydroxypyrimido\\[1,2-a\\]purine-10(3H)-one. Model adjusted for age, sex and race/ethnicity"}], 'secondaryOutcomes': [{'measure': 'εdAdo, Per 10^9 Nucleotides', 'timeFrame': 'Baseline', 'description': 'Lipid peroxidation-related adduct 1,N6-etheno-dAdo etheno-DNA adducts from peroxidation of lipids. Model adjusted for age, sex and race/ethnicity'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'DNA adducts in the oral mucosa cells of 100 smokers from 3 ethnic groups - Native Hawaiians, Whites, and Japanese Americans with differing risks for lung cancer upon cigarette smoking will be quantified. DNA adducts of tobacco smoke carcinogens will be quantified using both targeted and untargeted approaches.', 'detailedDescription': 'Using high resolution mass spectrometry, quantify known DNA adducts in oral mucosa cells of 100 smokers from each ethnic group - Native Hawaiians, Whites, and Japanese Americans. DNA adducts of tobacco-specific compounds, formaldehyde, and acrolein will be quantified.\n\n2\\. Analyze the urine of 100 smokers and 100 non-smokers from each of these groups for mercapturic acids of acrolein and crotonaldehyde, as well as total nicotine equivalents and total NNAL (smokers only). These data will provide critical information relevant to the high risk of Native Hawaiians for lung cancer, and in relationship to the DNA adduct measurements of Specific Aim 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '100 each of three ethnic groups: Native Hawaiians, Japanese Americans, whites', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* currently smoke at least 5 cigarettes per day, self-identified Japanese Americans, European Americans, or Native Hawaiians.\n\nExclusion Criteria:\n\n* no current use of other nicotine containing products, no acute or uncontrolled medical or psychiatric conditions, no greater than 14 alcoholic drinks per week, not pregnant, not breastfeeding, not currently taking any medications that affect relevant metabolic enzymes, no active infection.'}, 'identificationModule': {'nctId': 'NCT03285893', 'acronym': 'OCDNA', 'briefTitle': 'Oral Cell DNA Adducts in Smokers', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Quantitation of Oral Cell DNA Adducts in Smokers', 'orgStudyIdInfo': {'id': '2017NTLS019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Native Hawaiian cigarette smokers', 'description': 'oral cell DNA adducts', 'interventionNames': ['Other: oral cell DNA adducts']}, {'label': 'White (European Americans) cigarette smokers', 'description': 'oral cell DNA adducts', 'interventionNames': ['Other: oral cell DNA adducts']}, {'label': 'Japanese American cigarette smokers', 'description': 'oral cell DNA adducts', 'interventionNames': ['Other: oral cell DNA adducts']}], 'interventions': [{'name': 'oral cell DNA adducts', 'type': 'OTHER', 'description': 'oral cells will be collected, DNA isolated, and analyzed for adducts', 'armGroupLabels': ['Japanese American cigarette smokers', 'Native Hawaiian cigarette smokers', 'White (European Americans) cigarette smokers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Tobacco Use Research Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Stepehn Hecht, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Only unidentified data will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Hawaii', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}