Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure (AMORCE-CBP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|