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

September 2, 2019 updated by: N.N. Petrov National Medical Research Center of Oncology

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: 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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung cancer mortality
Time Frame: 5 years
Assess lung cancer mortality in the screened group within next 5 years.
5 years
All-cause mortality
Time Frame: 5 years
Assess all-cause mortality mortality within next 5 years.
5 years
Lung cancer detection rate
Time Frame: One year
Assess number of lung cancer diagnoses after radiological and morphological verification of positive lung nodules.
One year
Nodule detection rate
Time Frame: 3 months
Estimate nodule detection rate, types and sizes of lung nodules found.
3 months
Recruitment strategies
Time Frame: 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.
3 months

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RLCT-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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