Clinical trial NCT01248806: Continuous Observation of Smoking Subject
Official title: Validation of Low-dose Spiral CT for Early Diagnosis of Lung Cancer in a High Risk Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subjects at High Risk of Lung Cancer Due to Smoking
Keywords: Lung nodule
Screening
Spiral low - dose computed tomography
Lung cancer
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Associazione Italiana per la Ricerca sul Cancro
First posted: 2010-11-25
Enrollment: 5203
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To determine the prevalence of malignant pulmonary disease at the first CT examination
timeFrame: once after enrollment
measure: To assess the radiological detection of disease during the 10 year follow-up
timeFrame: once per year for a 10 year follow-up period
Secondary outcomes:
measure: To determine the overall resectability of detected malignant tumours
timeFrame: once after detection of malignancy
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Massimo Bellomi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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 nodules. Lung Cancer. 2008 Sep;61(3):340-9. doi: 10.1016/j.lungcan.2008.01.001. Epub 2008 Mar 4.
citation: 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.
citation: 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.