CT Screening For Lung Cancer in High Risk Patients: the Russian Study.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||Cohort Study of Low Dose Computed Tomography for Lung Cancer Screening in Asymptomatic High-risk Patients.|
- Estimate the time period for recruitment of 500 participants in LDCT screening study. [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
- Lung cancer detection rate [ Time Frame: One year ] [ Designated as safety issue: No ]Assess number of lung cancer diagnoses after radiological and morphological verification of positive lung nodules.
- All-cause mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]Assess all-cause mortality mortality within next 5 years.
- Lung cancer mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]Assess lung cancer mortality in the screened group within next 5 years.
- Nodule detection rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]Estimate nodule detection rate, types and sizes of lung nodules found.
- Recruitment strategies [ Time Frame: 3 months ] [ Designated as safety issue: No ]Assess the efficacy of different recruitment strategy in this study. Information about the study was shared between general practitioners, radiologists, pulmonologists, thoracic oncologist.
- Comparison of independent radiological evaluation of scans [ Time Frame: One year ] [ Designated as safety issue: No ]Comparison of independent radiological evaluation of scans performed by 2 independent specialists.
- Lung nodules management [ Time Frame: 12 months ] [ Designated as safety issue: No ]Assess algorithms for lung nodules management in regional oncology hospitals in Russian Federation.
- Frequency of diagnostic procedures. [ Time Frame: 12 months ] [ Designated as safety issue: No ]Estimate the frequency of diagnostic procedures, types of invasive and non-invasive procedures performed.
- Complication of diagnostic procedures [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Assess the complication rate after diagnostic procedures performed after screening. Procedures include baseline LDCT.
- Quality of Life [ Time Frame: 3 months ] [ Designated as safety issue: No ]Assess quality of life of patients during screening program.
|Study Start Date:||November 2012|
|Study Completion Date:||September 2016|
|Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Experimental: Low dose computed tomography
Patients will have one baseline LDCT scan.
Procedure: Low dose computed tomography
Low dose computed tomography scan
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752647
|Semashko City Clinical Hospital #2|
|Samara, Samara region, Russian Federation, 443008|
|Samara Regional Oncology Dispansery|
|Samara, Samara Region, Russian Federation, 443031|
|Study Chair:||Alexei Barchuk, MD PhD||Petrov Research Institute of Oncology|