Smoking
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTLow-dose chest CT scan
baseline, 1-year, 3-year and 5-year low-dose CT scan
Sponsors
Hospital St. Joseph, Marseille, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive Predictive Value (PPV) | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 5 years | smoking-related co-morbities = pulmonary emphysema, interstitial lung disease, atheromatous disease, hepatic steatosis and ascending aortic aneurysm. |
| Rate of additional examinations (including invasive diagnostic tests and surgery with benign results) | 5 years | — |
| Sensitivity | 5 years | — |
| Number of false positive results | 5 years | — |
| Penetration rate | 5 years | number of subjects included / number of includible subjects |
| Smoking cessation rates | 5 years | — |
| EORTC QLQ-C30 score (version 3) | 5 years | 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. |
| Risk ratio of lung cancer | 5 years | — |
Countries
France
Contacts
Primary ContactCecile Bielmann
Outcome results
None listed