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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose computed tomography | Experimental | Patients will have one baseline LDCT scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose computed tomography | Procedure | Low dose computed tomography scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lung cancer detection rate | Assess number of lung cancer diagnoses after radiological and morphological verification of positive lung nodules. | One year |
| All-cause mortality | Assess all-cause mortality mortality within next 5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of independent radiological evaluation of scans | Comparison of independent radiological evaluation of scans performed by 2 independent specialists. | One year |
| Lung nodules management | Assess algorithms for lung nodules management in regional oncology hospitals in Russian Federation. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexei Barchuk, MD PhD | N.N. Petrov National Medical Research Center of Oncology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semashko City Clinical Hospital #2 | Samara | Samara Oblast | 443008 | Russia | ||
| Samara Regional Oncology Dispansery |
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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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| 5 years |
| Lung cancer mortality | Assess lung cancer mortality in the screened group within next 5 years. | 5 years |
| Nodule detection rate | Estimate nodule detection rate, types and sizes of lung nodules found. | 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. | 3 months |
| 12 months |
| Frequency of diagnostic procedures. | Estimate the frequency of diagnostic procedures, types of invasive and non-invasive procedures performed. | 12 months |
| Complication of diagnostic procedures | Assess the complication rate after diagnostic procedures performed after screening. Procedures include baseline LDCT. | 12 months |
| Samara |
| Samara Oblast |
| 443031 |
| Russia |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |