This prospective cohort trial was planned to assess the feasibility of establishing a lung cancer screening program in Russian Federation using low-dose CT scanning in asymptomatic patients with at least a 30 pack-year history of cigarette smoking.
Low dose computer tomography (LDCT) showed promising results in recently published studied. Lung cancer screening programs with fluorography introduced in USSR in 70s-80s showed shift to earlier stages with no data on mortality. No other studies or programs on lung cancer screening were introduced in Russia since then. The purpose of this study is to assess the feasibility of establishing a lung cancer screening program in Russian Federation using LDCT scanning in asymptomatic patients with at least a 30 pack-year history of cigarette smoking. This cohort prospective study is planned to enroll at least 500 current or former smokers. Patients will be screened by LDCT scan at baseline with recommendation to perform follow-up in case of any positive result. For nodes more than 10 mm full clinical examination is recommended. For nodes 3-9.9 mm follow-up scans in 1, 3 or 6 months is recommended. For nodes smaller than 3 mm and negative results annual LDCT is recommended. Patient with positive results will be followed until final clinical diagnosis. Secondary outcomes include: * Lung cancer diagnoses * Lung cancer and overall mortality * Quality of life assessment * Complications of diagnostic and surgical procedures following a positive result. * Comparison of independent radiological evaluation of scans.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
369
Low dose computed tomography scan
Semashko City Clinical Hospital #2
Samara, Samara Oblast, Russia
Samara Regional Oncology Dispansery
Samara, Samara Oblast, Russia
Estimate the time period for recruitment of 500 participants in LDCT screening study.
Primary outcome measure is to assess the feasibility of establishing a lung cancer screening program in Russian Federation using low-dose CT scanning in asymptomatic patients with at least a 30 pack-year history of cigarette smoking. The main concern comes from the possibility to recruit participant for screening as small amount of information is available about lung cancer screening options for high-risk population and general practitioners in different regions of the country.
Time frame: 3 months
Lung cancer detection rate
Assess number of lung cancer diagnoses after radiological and morphological verification of positive lung nodules.
Time frame: One year
All-cause mortality
Assess all-cause mortality mortality within next 5 years.
Time frame: 5 years
Lung cancer mortality
Assess lung cancer mortality in the screened group within next 5 years.
Time frame: 5 years
Nodule detection rate
Estimate nodule detection rate, types and sizes of lung nodules found.
Time frame: 3 months
Recruitment strategies
Assess the efficacy of different recruitment strategy in this study. Information about the study was shared between general practitioners, radiologists, pulmonologists, thoracic oncologist.
Time frame: 3 months
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