Continuous Observation of Smoking Subject (COSMOS)

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.

Study Overview

• Status: Completed
• Conditions: Subjects at High Risk of Lung Cancer Due to Smoking
• Intervention / Treatment: 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
• Enrollment (Actual): 5203

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • European Institute of Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

community sample

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: High resoluzione CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the prevalence of malignant pulmonary disease at the first CT examination	CT scan	once after enrollment
To assess the radiological detection of disease during the 10 year follow-up	CT scan	once per year for a 10 year follow-up period

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine the overall resectability of detected malignant tumours	once after detection of malignancy

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Collaborators: Associazione Italiana per la Ricerca sul Cancro
• Investigators: Principal Investigator: Massimo Bellomi, PhD, European Institute of Oncology

Publications and helpful links

General Publications

• Veronesi G, Bellomi M, Mulshine JL, Pelosi G, Scanagatta P, Paganelli G, Maisonneuve P, Preda L, Leo F, Bertolotti R, Solli P, Spaggiari L. Lung cancer screening with low-dose computed tomography: a non-invasive diagnostic protocol for baseline lung nodules. Lung Cancer. 2008 Sep;61(3):340-9. doi: 10.1016/j.lungcan.2008.01.001. Epub 2008 Mar 4.
• Pelosi G, Sonzogni A, Veronesi G, De Camilli E, Maisonneuve P, Spaggiari L, Manzotti M, Masullo M, Taliento G, Fumagalli C, Bellomi M, Travis WD, Kadivar M, Viale G. Pathologic and molecular features of screening low-dose computed tomography (LDCT)-detected lung cancer: a baseline and 2-year repeat study. Lung Cancer. 2008 Nov;62(2):202-14. doi: 10.1016/j.lungcan.2008.03.012. Epub 2008 May 2.
• Veronesi G, Bellomi M, Veronesi U, Paganelli G, Maisonneuve P, Scanagatta P, Leo F, Pelosi G, Travaini L, Rampinelli C, Trifiro G, Sonzogni A, Spaggiari L. Role of positron emission tomography scanning in the management of lung nodules detected at baseline computed tomography screening. Ann Thorac Surg. 2007 Sep;84(3):959-65; discussion 965-6. doi: 10.1016/j.athoracsur.2007.04.058.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2004
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: November 24, 2010
• First Submitted That Met QC Criteria: November 24, 2010
• First Posted (Estimate): November 25, 2010

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 12, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Lung cancer; Screening; Lung nodule; Spiral low - dose computed tomography
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: IEO S39/100