Continuous Observation of Smoking Subject (COSMOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01248806
Recruitment Status : Active, not recruiting
First Posted : November 25, 2010
Last Update Posted : August 10, 2016
Associazione Italiana per la Ricerca sul Cancro
Information provided by (Responsible Party):
European Institute of Oncology

November 24, 2010
November 25, 2010
August 10, 2016
October 2004
January 2017   (Final data collection date for primary outcome measure)
  • To determine the prevalence of malignant pulmonary disease at the first CT examination [ Time Frame: once after enrollment ]
    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 ]
    CT scan
Same as current
Complete list of historical versions of study NCT01248806 on Archive Site
To determine the overall resectability of detected malignant tumours [ Time Frame: once after detection of malignancy ]
Same as current
Not Provided
Not Provided
Continuous Observation of Smoking Subject
Validation of Low-dose Spiral CT for Early Diagnosis of Lung Cancer in a High Risk Population
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.

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.

Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
whole blood, serum
Non-Probability Sample
community sample
Subjects at High Risk of Lung Cancer Due to Smoking
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
Smokers or former smokers, Aged ≥ 50
Men and women current daily smokers or former smokers, Aged ≥ 50
Intervention: Radiation: Low dose CT scan

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
December 2017
January 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
IEO S39/100
Not Provided
Not Provided
European Institute of Oncology
European Institute of Oncology
Associazione Italiana per la Ricerca sul Cancro
Principal Investigator: Massimo Bellomi, PhD European Institute of Oncology
European Institute of Oncology
August 2016