Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure (AMORCE-CBP)
|ClinicalTrials.gov Identifier: NCT01687647|
Recruitment Status : Enrolling by invitation
First Posted : September 19, 2012
Last Update Posted : April 9, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Neoplasms||Other: low-dose CT-scan AND induced sputum sample AND blood test||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||December 2019|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|