Cohort Study of Low Dose Computed Tomography for Lung Cancer Screening in Asymptomatic High-risk Patients.
50 Years
75 Years
Both
Lung Cancer
Trial Information
Cohort Study of Low Dose Computed Tomography for Lung Cancer Screening in Asymptomatic High-risk Patients.
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Outcome Measure:
Estimate the time period for recruitment of 500 participants in LDCT screening study.
Outcome Description:
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.
Outcome Time Frame:
3 months
Safety Issue:
No
Principal Investigator
Alexei Barchuk, MD PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Petrov Research Institute of Oncology
Authority:
Russia: Ministry of Health of the Russian Federation
Study ID:
RLCT-01
NCT ID:
NCT01752647
Start Date:
November 2012
Completion Date:
March 2013
Related Keywords:
- Lung Cancer
- lung cancer
- screening
- low dose
- computed tomography
- Lung Neoplasms
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