Clinical trial NCT02884232: Application of Guidelines for Medico-professional Supervision of Workers Exposed to Carcinogenic Action of Wood Dust: CERBois Cohort
Official title: Application of Guidelines for Medico-professional Supervision of Workers Exposed to Carcinogenic Action of Wood Dust: CERBois Cohort. Feasibility Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exposition to Wood Dust
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 800
Sex: ALL
Minimum age (years): 44
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
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
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: AHI 33
city: Lille
country: France
facility: Pôle Santé Travail
city: Paris
country: France
facility: Gnmst-Btp
city: Paris
country: France
facility: Ville de Paris
city: Suresnes
country: France
facility: ACMS
city: Vandoeuvre Les Nancy
country: France
facility: Centres de Consultations de Pathologies Professionnelles
Study officials:
affiliation: Centre de Consultations de Pathologies Professionnelles - Hôpitaux de Brabois - CHU de Nancy - France
name: Christophe PARIS, Pr
role: PRINCIPAL_INVESTIGATOR
References: