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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Procedure: Low dose computed tomography

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 Type: Interventional
• Enrollment (Actual): 369
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Samara Region
    • Samara, Samara Region, Russian Federation, 443008
      • Semashko City Clinical Hospital #2
    • Samara, Samara Region, Russian Federation, 443031
      • Samara Regional Oncology Dispansery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose computed tomography; Patients will have one baseline LDCT scan.	Procedure: Low dose computed tomography; Low dose computed tomography scan; Other Names: CT scan; LDCT scan

What is the study measuring?

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 mortality	Assess lung cancer mortality in the screened group within next 5 years.	5 years
All-cause mortality	Assess all-cause mortality mortality within next 5 years.	5 years
Lung cancer detection rate	Assess number of lung cancer diagnoses after radiological and morphological verification of positive lung nodules.	One year
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of independent radiological evaluation of scans	Comparison of independent radiological evaluation of scans performed by 2 independent specialists.	One year
Lung nodules management	Assess algorithms for lung nodules management in regional oncology hospitals in Russian Federation.	12 months
Frequency of diagnostic procedures.	Estimate the frequency of diagnostic procedures, types of invasive and non-invasive procedures performed.	12 months
Complication of diagnostic procedures	Assess the complication rate after diagnostic procedures performed after screening. Procedures include baseline LDCT.	12 months

Collaborators and Investigators

• Sponsor: N.N. Petrov National Medical Research Center of Oncology
• Investigators: Study Chair: Alexei Barchuk, MD PhD, N.N. Petrov National Medical Research Center of Oncology

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: December 13, 2012
• First Submitted That Met QC Criteria: December 16, 2012
• First Posted (Estimate): December 19, 2012

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 2, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: lung cancer; screening; computed tomography; low dose
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: RLCT-01