Interest of Morphometric Analysis of Sputum Cytology for Lung Cancer Screening in Workers Highly Exposed to Asbestos - Exploratory Analysis of Biomarkers Predictive for Lung Cancer
Phase 3
56 Years
N/A
56 Years
N/A
Open (Enrolling by invite only)
Both
Lung Neoplasms
Both
Lung Neoplasms
Trial Information
Interest of Morphometric Analysis of Sputum Cytology for Lung Cancer Screening in Workers Highly Exposed to Asbestos - Exploratory Analysis of Biomarkers Predictive for Lung Cancer
Inclusion Criteria:
- High professional asbestos exposure
- Member of a former cohort recruited between 2000 and 2006 in Caen, Rouen and Le Havre
(inclusion criteria: 50-75 years at the time of initial recruitment, high
intermittent asbestos exposure >= 1 year, or high discontinuous asbestos exposure
>=10 years). All the living members of the cohort will be contacted: a maximum of
1000 subjects is expected, probably less.
- Informed consent signed
Exclusion Criteria:
- Personal history of lung cancer
- Refusal of the study protocol
- Uncontrolled asthma or lung failure
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Screening
Outcome Measure:
Risk of false positive
Outcome Description:
Ratio of false positives (RFP) for detection of lung cancer in reference to conventional cytology analysis of sputum
Outcome Time Frame:
within 3 months
Safety Issue:
Yes
Principal Investigator
Lydia GUITTET, MD,PhD
Investigator Role:
Study Director
Investigator Affiliation:
Caen University Hospital, INSERM
Authority:
France: Committee for the Protection of Personnes
Study ID:
2011-A01380-41
NCT ID:
NCT01687647
Start Date:
September 2012
Completion Date:
December 2019
Related Keywords:
- Lung Neoplasms
- Lung cancer screening
- Asbestos exposed workers
- Sputum analysis
- Automated cytometry
- Predictive biomarkers
- Neoplasms
- Lung Neoplasms
Name | Location |
|---|
