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| Name | Class |
|---|---|
| Associazione Italiana per la Ricerca sul Cancro | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smokers or former smokers, Aged ≥ 50 | Men and women current daily smokers or former smokers, Aged ≥ 50 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose CT scan | Radiation | 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the overall resectability of detected malignant tumours | once after detection of malignancy |
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Inclusion Criteria:
Exclusion Criteria:
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community sample
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| Name | Affiliation | Role |
|---|---|---|
| Massimo Bellomi, PhD | European Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Milan | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18308420 | Result | 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. | |
| 18450320 |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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whole blood, serum
|
| 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. |
| 17720408 | Result | 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. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |