Overview

This trial is active, not recruiting.

Condition subjects at high risk of lung cancer due to smoking
Treatment low dose ct scan
Sponsor European Institute of Oncology
Collaborator Associazione Italiana per la Ricerca sul Cancro
Start date October 2004
End date January 2017
Trial size 5203 participants
Trial identifier NCT01248806, IEO S39/100

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective
Arm
Men and women current daily smokers or former smokers, Aged ≥ 50
low dose ct scan High resoluzione 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

Primary Outcomes

Measure
To determine the prevalence of malignant pulmonary disease at the first CT examination
time frame: once after enrollment
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

Secondary Outcomes

Measure
To determine the overall resectability of detected malignant tumours
time frame: once after detection of malignancy

Eligibility Criteria

Male or female participants at least 50 years old.

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

Additional Information

Official title Validation of Low-dose Spiral CT for Early Diagnosis of Lung Cancer in a High Risk Population
Principal investigator Massimo Bellomi, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by European Institute of Oncology.