CT Screening For Lung Cancer in High Risk Patients: the Russian Study.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cohort Study of Low Dose Computed Tomography for Lung Cancer Screening in Asymptomatic High-risk Patients.

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: Low dose computed tomography


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose computed tomography<br>Patients will have one baseline LDCT scan. | Procedure: Low dose computed tomography<br>* Low dose computed tomography scan<br>* Other names: LDCT scan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, screening, low dose, computed tomography