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

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.

Condition or disease Intervention/treatment
Subjects at High Risk of Lung Cancer Due to Smoking Radiation: Low dose 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.

Study Type : Observational
Actual Enrollment : 5203 participants
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
Study Start Date : October 2004
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. To determine the prevalence of malignant pulmonary disease at the first CT examination [ Time Frame: once after enrollment ]
    CT scan

  2. 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

Secondary Outcome Measures :
  1. To determine the overall resectability of detected malignant tumours [ Time Frame: once after detection of malignancy ]

Biospecimen Retention:   Samples With DNA
whole blood, serum

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01248806

European Institute of Oncology
Milan, Italy
Sponsors and Collaborators
European Institute of Oncology
Associazione Italiana per la Ricerca sul Cancro
Principal Investigator: Massimo Bellomi, PhD European Institute of Oncology

Publications of Results:
Responsible Party: European Institute of Oncology Identifier: NCT01248806     History of Changes
Other Study ID Numbers: IEO S39/100
First Posted: November 25, 2010    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016

Keywords provided by European Institute of Oncology:
Lung nodule
Spiral low - dose computed tomography
Lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases