Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2026-01-27 @ 7:17 AM
Study NCT ID:
NCT02884232
Status:
COMPLETED
Last Update Posted:
2016-08-30
First Post:
2016-08-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Guidelines for Medico-professional Supervision of Workers Exposed to Carcinogenic Action of Wood Dust: CERBois Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-25', 'studyFirstSubmitDate': '2016-08-23', 'studyFirstSubmitQcDate': '2016-08-25', 'lastUpdatePostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participation to medical supervision program of professionally active asymptomatic workers', 'timeFrame': 'Day 0'}, {'measure': 'Participation to medical supervision program of professionally active asymptomatic workers', 'timeFrame': '3 months'}, {'measure': 'Participation to medical supervision program of professionally active asymptomatic workers', 'timeFrame': '24 months'}, {'measure': 'Participation to medical supervision program of professionally active asymptomatic workers', 'timeFrame': '27 months'}], 'secondaryOutcomes': [{'measure': 'Former and actual professional expositions to wood dust and to various naso-sinusal carcinogenics', 'timeFrame': 'Day 0'}, {'measure': 'Presence of abnormal symptoms assessed by doctor, needing an otorhinolaryngology test', 'timeFrame': 'Day 0'}, {'measure': 'Presence of abnormal symptoms assessed by doctor, needing an otorhinolaryngology test', 'timeFrame': '24 months'}, {'measure': 'Counting of diagnoses of naso-sinusal adenocarcinoma in symptomatic and asymptomatic workers after nasofibroscopy', 'timeFrame': '3 months'}, {'measure': 'Counting of diagnoses of naso-sinusal adenocarcinoma in symptomatic and asymptomatic workers after nasofibroscopy', 'timeFrame': '27 months'}, {'measure': 'Participation to medical supervision program of workers retiring in 2 years after inclusion', 'timeFrame': 'Day 0'}, {'measure': 'Evaluation of information flow among different players', 'timeFrame': '3 months'}, {'measure': 'Evaluation of information flow among different players', 'timeFrame': '27 months'}, {'measure': 'Medical costs Induced by screening', 'timeFrame': '3 months'}, {'measure': 'Medical costs Induced by screening', 'timeFrame': '27 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Exposition to Wood Dust']}, 'descriptionModule': {'briefSummary': 'The purpose is to evaluate feasibility of medical supervision of professionally active asymptomatic wood workers with questionnaires and nasofibroscopy.\n\nSecondary purposes are:\n\n* Feasibility evaluation of identification of former and actual professional expositions to wood dust and to various naso-sinusal carcinogenics in case of co-expositions (formaldehyde, chrome, nickel, leather)\n* Description of abnormal symptoms identified by occupational doctor and needing an otorhinolaryngology test\n* Description of results and examinations induced by nasofibroscopy in symptomatic or asymptomatic individuals: counting of naso-sinusal adenocarcinoma cases\n* Evaluation of participation of workers retiring in 2 years after inclusion to medical supervision program\n* Evaluation of information flow among different players\n* Assessment of costs induced by this targeted screening: direct medical costs (screened pathologies, induced additional examinations…) and indirect costs for company (duration of worker absence for transfer, medical and additional examinations).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '44 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population under analysis consists of all workers seen in occupational health consultation and exposed to wood dust at least for cumulated 12 months and with first exposition back to more than 30 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Employee or craftsman\n* Actual or former professional exposition to wood dust\n* Onset of exposition to wood dust back to more than 30 years (latency \\>30 years)\n* Cumulated exposition to wood dust longer than 12 months\n* Exposition to wood dust during machining tasks (sawing, milling, planing, drilling, bridging) or all documented activities exposing to wood dust concentration \\> 1 mg/m3 for 8 hours\n* Worker followed by occupational doctor of participant occupational health departments\n* Worker accepting medico-professional supervision recommended by guidelines\n* Affiliation to social security\n\nExclusion Criteria:\n\n* Difficulty with comprehension of wood auto-questionnaire'}, 'identificationModule': {'nctId': 'NCT02884232', 'acronym': 'CERBois', 'briefTitle': 'Application of Guidelines for Medico-professional Supervision of Workers Exposed to Carcinogenic Action of Wood Dust: CERBois Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Application of Guidelines for Medico-professional Supervision of Workers Exposed to Carcinogenic Action of Wood Dust: CERBois Cohort. Feasibility Evaluation', 'orgStudyIdInfo': {'id': '2011/INCA/CERBOIS/PARIS-HERIN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Workers exposed to wood dust', 'interventionNames': ['Procedure: Nasofibroscopy']}], 'interventions': [{'name': 'Nasofibroscopy', 'type': 'PROCEDURE', 'armGroupLabels': ['Workers exposed to wood dust']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'facility': 'AHI 33', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Lille', 'country': 'France', 'facility': 'Pôle Santé Travail', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Paris', 'country': 'France', 'facility': 'Gnmst-Btp', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Ville de Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Suresnes', 'country': 'France', 'facility': 'ACMS', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Centres de Consultations de Pathologies Professionnelles', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Christophe PARIS, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre de Consultations de Pathologies Professionnelles - Hôpitaux de Brabois - CHU de Nancy - France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}