Lung Cancer Screening With Low-dose CT Scan in Women : Implementation Study

Study Overview
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Brief Summary
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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.

Detailed Description
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Lung cancer is the leading cause of cancer death, worldwide. Several randomized studies have demonstrated that annual or biennial low-dose CT screening reduces lung cancer mortality. However, these studies involved expert chest radiologists, with double reading being performed in most studies. Furthermore, none of the published studies have evaluated the role of artificial intelligence to serve as second of concurrent reader. Women with at least 25 pack-year smoking history who quitted smoking less than 15 years ago will be enrolled to have baseline, 1-year and 2-year low-dose CT of the chest. The CT scans will be read on site by a general radiologist trained to lung cancer screening according to the European lung cancer screening certification program, first without then with the aid of an artificial algorithm trained to lung nodule detection (Veye Chest, Aidence). All CT scans will also be read by 2 chest experts, who will resolve their disagreement by a consensus reading if necessary. Patient management will rely on the double reading by expert. The criteria for positive screen result are as follows: solid nodule > 500 mm3 (10 mm) or growing (30% volume increase), part-solid nodule with > 8 mm solid component or new or growing, pure ground glass nodule developing a solid portion.

Official Title
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Lung Cancer Screening With Low-dose CT Scan in Women : Implementation Study

Conditions
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Lung Cancer Screening

Intervention / Treatment
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* Procedure: Low-dose computed tomography of the chest


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria 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 Chest CT scan performed within 2 years prior to inclusion

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Procedure<br>Baseline low dose Ct acquisition, then at 1 year and 2 years to depict suspicious lung nodules | Procedure: Low-dose computed tomography of the chest<br>* Baseline low dose Ct acquisition, then at 1 year and 2 years to depict suspicious lung nodules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of trained radiologists for lung cancer screening | Sensitivity, specificity, predictive values compared to double reading by experts | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of screening | Proportion of participants with a positive screening test and proportion of confirmed diagnosis of cancer | 2 years | 
| Analysis of the diagnostic performance of the reading without detection software, in order to assess its incremental value | 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 | 2 years | 
| Analysis of the performance of a reading by detection software alone | Sensitivity, specificity, predictive values and likelihood ratios of artificial intelligence alone | 2 years | 
| Analysis of the concordances of the different readings | Kappa concordance coefficient between the different readings | 2 years | 
| Adherence to screening | Number of participants related to the number of eligible women, having completed all the required scans (3 to 6), speed of inclusion in the study | 2 years | 
| Analysis of the impact of screening on smoking cessation | Smoking cessation rate at the end of the study | 2 years | 
| Psychological impact of screening | HADS (Hospital Anxiety and Depression Scale) questionnaire at each scan, Cancer worry scale, Satisfaction with Decision scale at inclusion and end of study, all translated into French | 2 years | 
| Number of co-morbidities (COPD, coronary artery disease) detected | Number of participants related to the number of women included in the study for whom treatment is initiated (bronchodilators/ statins or revascularization/ osteoporosis treatment) | 2 years | 
| Evaluation of costs induced by screening | Cost measures: total cost of screening, average cost per woman, average cost per woman screened | 2 years | 
| Prevalence of osteoporosis by opportunistic screening | Presence of at least one thoracic vertebral fracture and measurement of trabecular attenuation of the T8 vertebral body | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung neoplasms, multidetector computed tomography, early detection of cancer, artificial intelligence, lung cancer screening