Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-01-05 @ 5:11 PM
Study NCT ID:
NCT05736250
Status:
UNKNOWN
Last Update Posted:
2023-02-21
First Post:
2023-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishment of a Method for Extraction and Quantification of Gingival Tissue Nicotine y
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073865', 'term': 'Cigarette Smoking'}], 'ancestors': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-16', 'studyFirstSubmitDate': '2023-01-24', 'studyFirstSubmitQcDate': '2023-02-16', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'nicotine', 'timeFrame': 'baseline', 'description': 'nicotine in gingival fibroblast'}, {'measure': 'nicotine dependance', 'timeFrame': 'baseline', 'description': 'Fagerström test for nicotine dependence'}], 'secondaryOutcomes': [{'measure': 'salivary cotinine', 'timeFrame': 'baseline'}, {'measure': 'number of cigarette consumed', 'timeFrame': 'baseline'}, {'measure': 'pack-year', 'timeFrame': 'baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking, Cigarette']}, 'descriptionModule': {'briefSummary': 'establishment of a method for extraction and quantification of gingival tissue nicotine in relation to conventional tobacco biomarkers: a pilot study', 'detailedDescription': 'The study aim to establish a method for extraction and quantification of gingival tissue nicotine. Additionnaly, the relationship between the nicotine tissue intoxication with others smoking indicators will be evaluated as mentionned in the following PICO question:\n\n* P: Smoker patients\n* I: Biopsie of gingival tissue\n* C: Non-smoker patient\n* O: nicotine dependence test (FTND), salivary cotinine, fibroblast nicotine, number of cigarette consumed per day (NCC) and the pack-year (PY)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'smoker patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non smokers\n* smokers\n\nExclusion Criteria:\n\n* not able to have biopsie'}, 'identificationModule': {'nctId': 'NCT05736250', 'briefTitle': 'Establishment of a Method for Extraction and Quantification of Gingival Tissue Nicotine y', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Establishment of a Method for Extraction and Quantification of Gingival Tissue Nicotine in Relation to Conventional Tobacco Biomarkers: a Pilot Study', 'orgStudyIdInfo': {'id': '2021:250'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TEST group', 'description': 'smoker patients', 'interventionNames': ['Diagnostic Test: biopsie']}], 'interventions': [{'name': 'biopsie', 'type': 'DIAGNOSTIC_TEST', 'description': 'gingival biopsie', 'armGroupLabels': ['TEST group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'state': 'Liege', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Leila Salhi, PhD', 'role': 'CONTACT'}], 'facility': 'Salhi', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'centralContacts': [{'name': 'Leila Salhi, PhD', 'role': 'CONTACT', 'email': 'l.salhi@chuliege.be', 'phone': '003243233123'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, head of clinic, Department of periodontology, buccal surgery and buccal implantology,', 'investigatorFullName': 'Leila Salhi', 'investigatorAffiliation': 'University of Liege'}}}}