NCT02884232

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

4 years

First QC Date

August 23, 2016

Last Update Submit

August 25, 2016

Conditions

Exposition to Wood Dust

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (1)

Workers exposed to wood dust

Procedure: Nasofibroscopy

Interventions

NasofibroscopyPROCEDURE
Workers exposed to wood dust

Eligibility Criteria

Age44 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Difficulty with comprehension of wood auto-questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

AHI 33

Bordeaux, France

Location

Pôle Santé Travail

Lille, France

Location

Gnmst-Btp

Paris, France

Location

Ville de Paris

Paris, France

Location

ACMS

Suresnes, France

Location

Centres de Consultations de Pathologies Professionnelles

Vandœuvre-lès-Nancy, France

Location

Study Officials

  • Christophe PARIS, Pr

    Centre de Consultations de Pathologies Professionnelles - Hôpitaux de Brabois - CHU de Nancy - France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2016

First Posted

August 30, 2016

Study Start

June 1, 2012

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 30, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)