Evaluation of Lung Cancer CT Screening Performance Among Former and Current Smokers

Study Overview
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Brief Summary
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Diagnostic performance of low-dose chest CT scan combined with lung-RADS classification (version 1.1) for lung cancer screening among former and current smokers.

Official Title
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Evaluation of Lung Cancer CT Screening Performance Among Former and Current Smokers: a Real Life Study

Conditions
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Smoking

Intervention / Treatment
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* Diagnostic Test: Low-dose chest CT scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 50-80 years old Active smoker (≥ 15 PA) or former smoker (≥ 15 PA) Exclusion Criteria: Recent history of chest CT scan (within 12 months) Person unable to climb 2 floors Weight > 140kg Personal history of cancer < 5 years (currently being monitored by thoracic imaging)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT scan<br> | Diagnostic Test: Low-dose chest CT scan<br>* baseline, 1-year, 3-year and 5-year low-dose CT scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Predictive Value (PPV) |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity |  | 5 years | 
| Specificity |  | 5 years | 
| Early stage lung cancer detection rate (stage I and II) |  | 5 years | 
| 5-year survival rate of patients who have undergone thoracic surgery |  | 5 years | 
| Rate of smoking-related co-morbidities detected on low-dose CT scan | smoking-related co-morbities = pulmonary emphysema, interstitial lung disease, atheromatous disease, hepatic steatosis and ascending aortic aneurysm. | 5 years | 
| Rate of additional examinations (including invasive diagnostic tests and surgery with benign results) |  | 5 years | 
| Risk ratio of lung cancer |  | 5 years | 
| Number of false positive results |  | 5 years | 
| Penetration rate | number of subjects included / number of includible subjects | 5 years | 
| Smoking cessation rates |  | 5 years | 
| EORTC QLQ-C30 score (version 3) | The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The EORTC QLQ-C30 is composed of 9 multi-item scales: 5 functioning scales (physical, role, cognitive, emotional and social), a global QOL scale, and 3 symptom scales (fatigue, pain and nausea/vomiting). In addition, several single item symptom measures are used. For the five functioning scales and the global quality of life scale, a higher score represents a better level of functioning. For the symptom scales and items, a high score corresponds to a higher level of symptomatology. | 5 years |