Continuous Observation of Smoking Subject

Subjects at High Risk of Lung Cancer Due to Smoking Clinical Trial

— COSMOS  

Official title:

Validation of Low-dose Spiral CT for Early Diagnosis of Lung Cancer in a High Risk Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248806
• Other study ID #: IEO S39/100
• Status: Completed
• Start date: October 2004
• Est. completion date: December 2021

Study information

• Verified date: May 2022
• Source: European Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5203
• Est. completion date: December 2021
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Subjects at High Risk of Lung Cancer Due to Smoking

Intervention

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

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (2)

Lead Sponsor	Collaborator
European Institute of Oncology	Associazione Italiana per la Ricerca sul Cancro

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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)-detect — View Citation

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 nodul — View Citation

Veronesi G, Bellomi M, Veronesi U, Paganelli G, Maisonneuve P, Scanagatta P, Leo F, Pelosi G, Travaini L, Rampinelli C, Trifirò G, Sonzogni A, Spaggiari L. Role of positron emission tomography scanning in the management of lung nodules detected at baselin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the prevalence of malignant pulmonary disease at the first CT examination	CT scan	once after enrollment
Primary	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	To determine the overall resectability of detected malignant tumours		once after detection of malignancy