Application of Guidelines for Medico-professional Supervision of Workers Exposed to Carcinogenic Action of Wood Dust: CERBois Cohort (CERBois)

Application of Guidelines for Medico-professional Supervision of Workers Exposed to Carcinogenic Action of Wood Dust: CERBois Cohort. Feasibility Evaluation

The purpose is to evaluate feasibility of medical supervision of professionally active asymptomatic wood workers with questionnaires and nasofibroscopy.

Secondary purposes are:

• 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)
• Description of abnormal symptoms identified by occupational doctor and needing an otorhinolaryngology test
• Description of results and examinations induced by nasofibroscopy in symptomatic or asymptomatic individuals: counting of naso-sinusal adenocarcinoma cases
• Evaluation of participation of workers retiring in 2 years after inclusion to medical supervision program
• Evaluation of information flow among different players
• 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).

Study Overview

• Status: Completed
• Conditions: Exposition to Wood Dust
• Intervention / Treatment: Procedure: Nasofibroscopy

• Study Type: Observational
• Enrollment (Actual): 800

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • AHI 33
  • Lille, France
    • Pôle Santé Travail
  • Paris, France
    • Gnmst-Btp
  • Paris, France
    • Ville de Paris
  • Suresnes, France
    • ACMS
  • Vandoeuvre Les Nancy, France
    • Centres de Consultations de Pathologies Professionnelles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 44 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Employee or craftsman
• Actual or former professional exposition to wood dust
• Onset of exposition to wood dust back to more than 30 years (latency >30 years)
• Cumulated exposition to wood dust longer than 12 months
• 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
• Worker followed by occupational doctor of participant occupational health departments
• Worker accepting medico-professional supervision recommended by guidelines
• Affiliation to social security

Exclusion Criteria:

• Difficulty with comprehension of wood auto-questionnaire

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Workers exposed to wood dust	Procedure: Nasofibroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Participation to medical supervision program of professionally active asymptomatic workers	Day 0
Participation to medical supervision program of professionally active asymptomatic workers	3 months
Participation to medical supervision program of professionally active asymptomatic workers	24 months
Participation to medical supervision program of professionally active asymptomatic workers	27 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Former and actual professional expositions to wood dust and to various naso-sinusal carcinogenics	Day 0
Presence of abnormal symptoms assessed by doctor, needing an otorhinolaryngology test	Day 0
Presence of abnormal symptoms assessed by doctor, needing an otorhinolaryngology test	24 months
Counting of diagnoses of naso-sinusal adenocarcinoma in symptomatic and asymptomatic workers after nasofibroscopy	3 months
Counting of diagnoses of naso-sinusal adenocarcinoma in symptomatic and asymptomatic workers after nasofibroscopy	27 months
Participation to medical supervision program of workers retiring in 2 years after inclusion	Day 0
Evaluation of information flow among different players	3 months
Evaluation of information flow among different players	27 months
Medical costs Induced by screening	3 months
Medical costs Induced by screening	27 months

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Christophe PARIS, Pr, Centre de Consultations de Pathologies Professionnelles - Hôpitaux de Brabois - CHU de Nancy - France

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: August 23, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Estimate): August 30, 2016
• Last Update Submitted That Met QC Criteria: August 25, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2011/INCA/CERBOIS/PARIS-HERIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO