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

Lung Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

• NCT number: NCT01752647
• Study type: Interventional
• Source: N.N. Petrov National Medical Research Center of Oncology
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Completion date: September 2016