Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lung Neoplasms

Intervention / Treatment
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* Other: low-dose CT-scan AND induced sputum sample AND blood test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 56 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Screening<br>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<br>* All subjects will receive a low-dose CT-scan, a blood test (ancillary study) and provide an induced sputum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of false positive | Ratio of false positives (RFP) for detection of lung cancer in reference to conventional cytology analysis of sputum | within 3 months | 
| detection of lung cancer | Ratio of sensitivities for detection of lung cancer in reference to conventionnal cytology analysis of sputum | within 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity for lung cancer detection compared with CT-scan | 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. | within 3 months | 
| Specificity for detection of lung cancer | 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. | within 3 months | 
| Predictive Biomarkers | Frequency of specific biomarkers at the time of screening. Links between lung cancer during 5 years of prospective follow-up. | Annually during a maximum of 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer screening, Asbestos exposed workers, Sputum analysis, Automated cytometry, Predictive biomarkers