Continuous Observation of Smoking Subject (COSMOS)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Subjects at High Risk of Lung Cancer Due to Smoking |
Radiation: Low dose CT scan |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | Validation of Low-dose Spiral CT for Early Diagnosis of Lung Cancer in a High Risk Population |
- To determine the prevalence of malignant pulmonary disease at the first CT examination [ Time Frame: once after enrollment ] [ Designated as safety issue: No ]CT scan
- 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 ] [ Designated as safety issue: No ]CT scan
- To determine the overall resectability of detected malignant tumours [ Time Frame: once after detection of malignancy ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
whole blood, serum
| Enrollment: | 5203 |
| Study Start Date: | October 2004 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Smokers or former smokers, Aged ≥ 50
Men and women current daily smokers or former smokers, Aged ≥ 50
|
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
Other Name: High resoluzione CT scan
|
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
community sample
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
Contacts and Locations| Italy | |
| European Institute of Oncology | |
| Milan, Italy | |
| Principal Investigator: | Massimo Bellomi, PhD | European Institute of Oncology |
More Information
Publications:
| Responsible Party: | European Institute of Oncology |
| ClinicalTrials.gov Identifier: | NCT01248806 History of Changes |
| Other Study ID Numbers: | IEO S39/100 |
| Study First Received: | November 24, 2010 |
| Last Updated: | November 28, 2011 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by European Institute of Oncology:
|
Lung nodule Screening Spiral low - dose computed tomography Lung cancer |
Additional relevant MeSH terms:
|
Lung Neoplasms Smoking Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Habits |
ClinicalTrials.gov processed this record on May 23, 2013