Exposition to Wood Dust Clinical Trial
— CERBoisOfficial title:
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).
| Status | Completed |
| Enrollment | 800 |
| Est. completion date | June 2016 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 44 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | AHI 33 | Bordeaux | |
| France | Pôle Santé Travail | Lille | |
| France | Gnmst-Btp | Paris | |
| France | Ville de Paris | Paris | |
| France | ACMS | Suresnes | |
| France | Centres de Consultations de Pathologies Professionnelles | Vandoeuvre Les Nancy |
| Lead Sponsor | Collaborator |
|---|---|
| Central Hospital, Nancy, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Participation to medical supervision program of professionally active asymptomatic workers | Day 0 | No | |
| Primary | Participation to medical supervision program of professionally active asymptomatic workers | 3 months | No | |
| Primary | Participation to medical supervision program of professionally active asymptomatic workers | 24 months | No | |
| Primary | Participation to medical supervision program of professionally active asymptomatic workers | 27 months | No | |
| Secondary | Former and actual professional expositions to wood dust and to various naso-sinusal carcinogenics | Day 0 | No | |
| Secondary | Presence of abnormal symptoms assessed by doctor, needing an otorhinolaryngology test | Day 0 | No | |
| Secondary | Presence of abnormal symptoms assessed by doctor, needing an otorhinolaryngology test | 24 months | No | |
| Secondary | Counting of diagnoses of naso-sinusal adenocarcinoma in symptomatic and asymptomatic workers after nasofibroscopy | 3 months | No | |
| Secondary | Counting of diagnoses of naso-sinusal adenocarcinoma in symptomatic and asymptomatic workers after nasofibroscopy | 27 months | No | |
| Secondary | Participation to medical supervision program of workers retiring in 2 years after inclusion | Day 0 | No | |
| Secondary | Evaluation of information flow among different players | 3 months | No | |
| Secondary | Evaluation of information flow among different players | 27 months | No | |
| Secondary | Medical costs Induced by screening | 3 months | No | |
| Secondary | Medical costs Induced by screening | 27 months | No |