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Completed

NCT Number: NCT01752647

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

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samara Regional Oncology Dispansery, Samara, Samara Oblast, Russia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low dose computed tomography

Procedure

Low dose computed tomography scan

Other names: CT scan, LDCT scan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Lung cancer detection rate

    Time frame: One year

    Assess number of lung cancer diagnoses after radiological and morphological verification of positive lung nodules.

  2. All-cause mortality

    Time frame: 5 years

    Assess all-cause mortality mortality within next 5 years.

  3. Lung cancer mortality

    Time frame: 5 years

    Assess lung cancer mortality in the screened group within next 5 years.

  4. Nodule detection rate

    Time frame: 3 months

    Estimate nodule detection rate, types and sizes of lung nodules found.

  5. 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.

Other outcomes

  1. Comparison of independent radiological evaluation of scans

    Time frame: One year

    Comparison of independent radiological evaluation of scans performed by 2 independent specialists.

  2. Lung nodules management

    Time frame: 12 months

    Assess algorithms for lung nodules management in regional oncology hospitals in Russian Federation.

  3. Frequency of diagnostic procedures.

    Time frame: 12 months

    Estimate the frequency of diagnostic procedures, types of invasive and non-invasive procedures performed.

  4. Complication of diagnostic procedures

    Time frame: 12 months

    Assess the complication rate after diagnostic procedures performed after screening. Procedures include baseline LDCT.

Sponsors and collaborators

Lead sponsor

N.N. Petrov National Medical Research Center of Oncology

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 19, 2012
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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