Continuous Observation of Smoking Subject

Study Overview
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Brief Summary
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The purpose of this study is to offer annual low-dose spiral CT radiological examination for 5 years to 5000 volunteers from the general population who are considered to be at high risk of developing lung cancer.

Detailed Description
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Lung carcinoma is one the most fatal cancer in the world. The enormous fatality rate reflects the limited chance of cure, with a dismal overall 5-year survival rate of approximately 14%. The prognosis of lung cancer depends largely on early detection and immediate treatment prior to metastatic spread. For Stage 1 lung cancer the 5-year survival rate can be as high as 70% . These data suggest that early detection and surgical treatment would have a huge beneficial effect on the lung cancer population. We developed a single arm observational study for the early detection of lung cancer with low dose CT scan in high risk asymptomatic subjects. A mainly non invasive algorithm for management of undetermined nodules was designed including low dose CT at three months for baseline nodules with diameter between 5 and 8 mm, a PET scan for nodules larger that 8 mm (not reduced after antibiotics and one month follow up CT). Lesions increasing in diameter or in density or positive nodules at CT/PET were sent to surgical biopsy (videothoracoscopic approach preferred). Spirometry was done in all subjects prior to CT scan to evaluate correlation between BPCO and lung cancer.

Official Title
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Validation of Low-dose Spiral CT for Early Diagnosis of Lung Cancer in a High Risk Population

Conditions
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Subjects at High Risk of Lung Cancer Due to Smoking

Intervention / Treatment
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* Radiation: Low dose CT scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 50 Current daily smokers or former smokers (total dose ≥ 20 pack/year, calculated by multiplying the number of packs per day by the total number of years smoked) Former smoker should have stopped smoking within the 10 years before the inclusion in the study protocol Exclusion Criteria: Not currently suffering from malignant disease or having had malignant disease within the last 5 years Not having known pulmonary pathology Not having performed a chest CT scan during the last 2 years

Ages Eligible for Study
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Minimum Age: 50 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Smokers or former smokers, Aged ≥ 50<br>Men and women current daily smokers or former smokers, Aged ≥ 50 | Radiation: Low dose CT scan<br>* A low dose CT scan of the lungs is performed after the inclusion of the patient in the study and if negative for active disease, a CT scan if performed once per year for whole period of follow-up<br>* Other names: High resoluzione CT scan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the prevalence of malignant pulmonary disease at the first CT examination | CT scan | once after enrollment | 
| To assess the radiological detection of disease during the 10 year follow-up | CT scan | once per year for a 10 year follow-up period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the overall resectability of detected malignant tumours |  | once after detection of malignancy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung nodule, Screening, Spiral low - dose computed tomography, Lung cancer