Spots Global Cancer Trial Database for Continuous Observation of Smoking Subject

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Trial Identification

Brief Title: Continuous Observation of Smoking Subject

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

Study ID: NCT01248806

Conditions

Subjects at High Risk of Lung Cancer Due to Smoking

Interventions

Low dose CT scan

Study Description

Brief Summary: 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: 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.