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| ID | Type | Description | Link |
|---|---|---|---|
| PHRC11-221 | Other Grant/Funding Number | French Ministry of Health (DGOS) |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening | Other | Paired-design: low-dose CT scan, sputum sample and blood test will be performed on all subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-dose CT-scan AND induced sputum sample AND blood test | Other | All subjects will receive a low-dose CT-scan, a blood test (ancillary study) and provide an induced sputum |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lydia GUITTET, MD,PhD | Caen University Hospital, INSERM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caen University Hospital | Caen | 14000 | France | |||
| Le Havre Hospital |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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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 |
| Le Havre |
| 76600 |
| France |
| Rouen University Hospital | Rouen | 76031 | France |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |