Lung Cancer
Conditions
Keywords
lung cancer, screening, low dose, computed tomography
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURELow dose computed tomography
Low dose computed tomography scan
Sponsors
N.N. Petrov National Medical Research Center of Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 50-75 years * 30 or more pack-years of cigarette smoking history * Former smokers: quit smoking within the previous 10 years * Ability to tolerate CT procedure * Signed informed consent
Exclusion criteria
* Any cancer other than nonmelanoma skin cancer or carcinoma in situ in the 5 years prior to eligibility assessment * Severe uncontrolled heart, vascular, respiratory or endocrine pathology. * Life-expectancy less than 1 year * History of lung cancer * History of lung surgery. * Acute respiratory disease * Hemoptysis. * Weight loss more than 10 kg in the 12 months prior to eligibility assessment * Participation in other cancer clinical trial * Chest CT examination in the 12 months prior to eligibility assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimate the time period for recruitment of 500 participants in LDCT screening study. | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 5 years | Assess all-cause mortality mortality within next 5 years. |
| Lung cancer detection rate | One year | Assess number of lung cancer diagnoses after radiological and morphological verification of positive lung nodules. |
| Lung cancer mortality | 5 years | Assess lung cancer mortality in the screened group within next 5 years. |
| Nodule detection rate | 3 months | Estimate nodule detection rate, types and sizes of lung nodules found. |
| Recruitment strategies | 3 months | Assess the efficacy of different recruitment strategy in this study. Information about the study was shared between general practitioners, radiologists, pulmonologists, thoracic oncologist. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Frequency of diagnostic procedures. | 12 months | Estimate the frequency of diagnostic procedures, types of invasive and non-invasive procedures performed. |
| Complication of diagnostic procedures | 12 months | Assess the complication rate after diagnostic procedures performed after screening. Procedures include baseline LDCT. |
| Lung nodules management | 12 months | Assess algorithms for lung nodules management in regional oncology hospitals in Russian Federation. |
| Comparison of independent radiological evaluation of scans | One year | Comparison of independent radiological evaluation of scans performed by 2 independent specialists. |
Countries
Russia
Outcome results
None listed