NCT01248806

Continuous Observation of Smoking Subject

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,203 (actual)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Subjects at High Risk of Lung Cancer Due to Smoking

Interventions

Type	Name	Description
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

Timeline

• Start date: 2004-10-01
• Primary completion: 2017-01-01
• Completion: 2021-12-01
• First posted: 2010-11-25
• Last updated: 2022-05-13

Locations

1 site across 1 country: Italy