Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT01237912
Status:
COMPLETED
Last Update Posted:
2019-11-07
First Post:
2010-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
European Exposure Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1667}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-05', 'studyFirstSubmitDate': '2010-11-09', 'studyFirstSubmitQcDate': '2010-11-09', 'lastUpdatePostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the exposure of adult smokers and non-smokers to cigarette smoke constituents', 'timeFrame': '2 consecutive visits within 14 days', 'description': 'To determine the exposure of adult smokers and non-smokers to the following cigarette smoke constituents: carbon monoxide, nicotine, acrolein, benzene, 1,3-butadiene, 4-aminobiphenyl (4-ABP), 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), o-toluidine, pyrene (1-OHP), 2-aminonaphthalene (2-NA).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Smoking']}, 'referencesModule': {'references': [{'pmid': '21613391', 'type': 'RESULT', 'citation': 'Lindner D, Smith S, Leroy CM, Tricker AR. Comparison of exposure to selected cigarette smoke constituents in adult smokers and nonsmokers in a European, multicenter, observational study. Cancer Epidemiol Biomarkers Prev. 2011 Jul;20(7):1524-36. doi: 10.1158/1055-9965.EPI-10-1186. Epub 2011 May 25.'}]}, 'descriptionModule': {'briefSummary': 'The current study was designed to determine the exposure of adult smokers and non-smokers to cigarette smoke constituents through evaluation of selected biomarkers of exposure.', 'detailedDescription': 'The purpose of the study was to provide a greater knowledge about human exposure to cigarette smoke constituents by evaluating selected biomarkers of exposure in smokers and non-smokers. This was an observational, parallel-group study to be conducted at multiple centres in the UK, Germany, and Switzerland. It was planned to enrol sufficient subjects such that at least 1440 subjects complete the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male or female 21 years of age or older with a stable health status as determined by the Investigator and who were able to understand the subject information and to comply with the study procedures and study schedule.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSmokers: Subjects who smoked commercial cigarettes exclusively (less than or equal to 10 mg ISO tar yield in Germany and the UK; less than or equal to 12 mg ISO tar yield in Switzerland) with a regular consumption of at least 1 cigarette per day over the last 12 months without change in brand over the previous 3 months.\n\nor\n\nNon-smokers: Subjects who did not smoke commercial cigarettes, hand-rolled cigarettes, cigars, pipes, bidis, and did not use other nicotine-containing products (patch, gum, lozenges etc.) within 1 year prior to Visit 1 and throughout the study duration.\n\nExclusion Criteria:\n\n* Female subjects with child-bearing potential were to be excluded if\n\n 1. Subject was pregnant (or did not have negative pregnancy tests) or breast-feeding\n 2. Subject did not agree to use an acceptable method of contraception'}, 'identificationModule': {'nctId': 'NCT01237912', 'briefTitle': 'European Exposure Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philip Morris Products S.A.'}, 'officialTitle': 'A European, Multi-centre Study to Determine the Exposure of Adult Smokers and Non-smokers to Cigarette Smoke Constituents', 'orgStudyIdInfo': {'id': 'SPA0403'}}, 'contactsLocationsModule': {'locations': [{'zip': 'BT96AD', 'city': 'Belfast', 'state': 'Northern Ireland', 'country': 'United Kingdom', 'facility': 'Stephen Smith', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}], 'overallOfficials': [{'name': 'Stephen Smith', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Celerion, 22-24 Lisburn Road, Belfast, BT9 6AD, Northern Ireland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philip Morris Products S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}