Continuous Observation of Smoking Subject

Completed

• Conditions: Subjects at High Risk of Lung Cancer Due to Smoking
• Interventions: Radiation: Low dose CT scan

• Registration Number: NCT01248806
• Lead Sponsor: European Institute of Oncology

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.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2010-11-24
• Study First Submitted QC: 2010-11-24
• Study First Posted: 2010-11-25
• Primary Completion: 2017-01
• Study Completion: 2021-12
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-12
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5203

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Smokers or former smokers, Aged ≥ 50	Low dose CT scan	Men and women current daily smokers or former smokers, Aged ≥ 50

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To determine the overall resectability of detected malignant tumours	once after detection of malignancy

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, Italy