Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure (AMORCE-CBP)
Workers exposed to asbestos are at high risk of lung cancer. Medical follow-up of this population relies on repeated CT-scans which are more accurate for detection of peripheral lesions, and expose to X-rays and to risk of false-positives. Analysis of sputum using automate cytometry may be of interest in this population, alone or in combination with CT-scan.
An ancillary study will evaluate the interest of blood predictive biomarkers.
|Lung Neoplasms||Other: low-dose CT-scan AND induced sputum sample AND blood test||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Screening
|Official Title:||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|
- Risk of false positive [ Time Frame: within 3 months ]Ratio of false positives (RFP) for detection of lung cancer in reference to conventional cytology analysis of sputum
- detection of lung cancer [ Time Frame: within 3 months ]Ratio of sensitivities for detection of lung cancer in reference to conventionnal cytology analysis of sputum
- Sensitivity for lung cancer detection compared with CT-scan [ Time Frame: within 3 months ]
Ratio of sensitivity (RSN) for lung cancer detection in reference with CT scan.
Interest of the combination "cytometry + CT-scan" compared with CT-scan alone will also be evaluated.
- Specificity for detection of lung cancer [ Time Frame: within 3 months ]
Ratio of false positives (RFP) of automated cytometry analysis compared with CT-scan screening.
The combination "automated cytometry + CTscan" will also be evaluated compared with CT scan alone.
- Predictive Biomarkers [ Time Frame: Annually during a maximum of 5 years ]Frequency of specific biomarkers at the time of screening. Links between lung cancer during 5 years of prospective follow-up.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Paired-design: low-dose CT scan, sputum sample and blood test will be performed on all subjects.
Other: low-dose CT-scan AND induced sputum sample AND blood test
All subjects will receive a low-dose CT-scan, a blood test (ancillary study) and provide an induced sputum
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687647
|Caen University Hospital|
|Caen, France, 14000|
|Le Havre Hospital|
|Le Havre, France, 76600|
|Rouen University Hospital|
|Rouen, France, 76031|
|Study Director:||Lydia GUITTET, MD,PhD||Caen University Hospital, INSERM|