Continuous Observation of Smoking Subject (COSMOS)
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.
Subjects at High Risk of Lung Cancer Due to Smoking
Radiation: Low dose CT scan
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||Validation of Low-dose Spiral CT for Early Diagnosis of Lung Cancer in a High Risk Population|
- To determine the prevalence of malignant pulmonary disease at the first CT examination [ Time Frame: once after enrollment ] [ Designated as safety issue: No ]CT scan
- To assess the radiological detection of disease during the 10 year follow-up [ Time Frame: once per year for a 10 year follow-up period ] [ Designated as safety issue: No ]CT scan
- To determine the overall resectability of detected malignant tumours [ Time Frame: once after detection of malignancy ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
whole blood, serum
|Study Start Date:||October 2004|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Smokers or former smokers, Aged ≥ 50
Men and women current daily smokers or former smokers, Aged ≥ 50
Radiation: Low dose CT scan
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
Other Name: High resoluzione CT scan
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.
|European Institute of Oncology|
|Principal Investigator:||Massimo Bellomi, PhD||European Institute of Oncology|