Continuous Observation of Smoking Subject

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-10-31

Study Completion Date

2021-12-31

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.

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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.

Conditions

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Subjects at High Risk of Lung Cancer Due to Smoking

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Smokers or former smokers, Aged ≥ 50

Men and women current daily smokers or former smokers, Aged ≥ 50

Low dose CT scan

Intervention Type RADIATION

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

Interventions

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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

Intervention Type RADIATION

Other Intervention Names

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High resoluzione CT scan

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No