Completed
NCT Number: NCT02884232
Application of Guidelines for Medico-professional Supervision of Workers Exposed to Carcinogenic Action of Wood Dust: CERBois Cohort
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).
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Notify MeKey information
Conditions
Age range
44 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
AHI 33, Bordeaux, France
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Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Participation to medical supervision program of professionally active asymptomatic workers
Time frame: Day 0
-
Participation to medical supervision program of professionally active asymptomatic workers
Time frame: 3 months
-
Participation to medical supervision program of professionally active asymptomatic workers
Time frame: 24 months
-
Participation to medical supervision program of professionally active asymptomatic workers
Time frame: 27 months
Secondary outcomes
-
Former and actual professional expositions to wood dust and to various naso-sinusal carcinogenics
Time frame: Day 0
-
Presence of abnormal symptoms assessed by doctor, needing an otorhinolaryngology test
Time frame: Day 0
-
Presence of abnormal symptoms assessed by doctor, needing an otorhinolaryngology test
Time frame: 24 months
-
Counting of diagnoses of naso-sinusal adenocarcinoma in symptomatic and asymptomatic workers after nasofibroscopy
Time frame: 3 months
-
Counting of diagnoses of naso-sinusal adenocarcinoma in symptomatic and asymptomatic workers after nasofibroscopy
Time frame: 27 months
-
Participation to medical supervision program of workers retiring in 2 years after inclusion
Time frame: Day 0
-
Evaluation of information flow among different players
Time frame: 3 months
-
Evaluation of information flow among different players
Time frame: 27 months
-
Medical costs Induced by screening
Time frame: 3 months
-
Medical costs Induced by screening
Time frame: 27 months
Sponsors and collaborators
Lead sponsor
Central Hospital, Nancy, France
Other
Registry information
Official study title
Application of Guidelines for Medico-professional Supervision of Workers Exposed to Carcinogenic Action of Wood Dust: CERBois Cohort. Feasibility Evaluation
Acronym: CERBois
Important dates
- Study start
- 2012
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Aug 30, 2016
- Registry last updated
- Aug 30, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.