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

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Procedure: Low dose computed tomography

• Registration Number: NCT01752647
• Lead Sponsor: N.N. Petrov National Medical Research Center of Oncology

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-12-13
• Study First Submitted QC: 2012-12-16
• Study First Posted: 2012-12-19
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-02
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 369

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low dose computed tomography	Low dose computed tomography	Patients will have one baseline LDCT scan.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
All-cause mortality	5 years	Assess all-cause mortality mortality within next 5 years.
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.
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.

Trial Locations

Locations (2)

Semashko City Clinical Hospital #2; 🇷🇺 Samara, Samara Region, Russian Federation

Samara Regional Oncology Dispansery; 🇷🇺 Samara, Samara Region, Russian Federation