The purpose of this study is to determine whether reading of low-dose thoracic CT scans can be done by a single general radiologist who has been trained to lung cancer screening, and will evaluate the performance in comparison with double reading by experts.
The study will enroll women between 50 and 74 years old, at risk for lung cancer due to their smoking history.
Women aged from 50 to 74 years
who had smoked at least 20 pack years and quit less than 15 years ago
Had given their consent and accepted the need for a 2-year follow-up
Affiliated to the social security system
Presence of clinical symptoms suggesting malignancy (weight loss, hemoptysis) or ongoing infection (cough with fever)
Evolving cancer
History of lung cancer
A 2-year follow-up not possible
Single group
Low-dose computed tomography of the chest
Procedure/SurgeryBaseline low dose Ct acquisition, then at 1 year and 2 years to depict suspicious lung nodules
Performance of trained radiologists for lung cancer screening
Sensitivity, specificity, predictive values compared to double reading by experts
Effectiveness of screening
Proportion of participants with a positive screening test and proportion of confirmed diagnosis of cancer
Analysis of the diagnostic performance of the reading without detection software, in order to assess its incremental value
For the general population and for the COPD population. Sensitivity, specificity, predictive values and likelihood ratios of the initial reading compared to the expert readings, using histological diagnosis as gold standard for positive screens and stability at 2 years for negative screens
Analysis of the performance of a reading by detection software alone
For the general population and for the COPD population. Sensitivity, specificity, predictive values and likelihood ratios of artificial intelligence alone
Analysis of the concordances of the different readings
Kappa concordance coefficient between the different readings
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
Ministère de la Santé et des Solidarités
Collaborator
National Cancer Institute, France
Collaborator
URC-CIC Paris Descartes Necker Cochin
Collaborator
