Clinical trial NCT01752647: CT Screening For Lung Cancer in High Risk Patients: the Russian Study.
Official title: Cohort Study of Low Dose Computed Tomography for Lung Cancer Screening in Asymptomatic High-risk Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: lung cancer
screening
low dose
computed tomography
Lead sponsor: N.N. Petrov National Medical Research Center of Oncology
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 369
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Estimate the time period for recruitment of 500 participants in LDCT screening study.
timeFrame: 3 months
Secondary outcomes:
measure: Lung cancer detection rate
timeFrame: One year
measure: All-cause mortality
timeFrame: 5 years
measure: Lung cancer mortality
timeFrame: 5 years
measure: Nodule detection rate
timeFrame: 3 months
measure: Recruitment strategies
timeFrame: 3 months
Other outcomes:
measure: Comparison of independent radiological evaluation of scans
timeFrame: One year
measure: Lung nodules management
timeFrame: 12 months
measure: Frequency of diagnostic procedures.
timeFrame: 12 months
measure: Complication of diagnostic procedures
timeFrame: 12 months
Locations:
city: Samara
country: Russian Federation
facility: Semashko City Clinical Hospital #2
state: Samara Region
city: Samara
country: Russian Federation
facility: Samara Regional Oncology Dispansery
state: Samara Region
Study officials:
affiliation: N.N. Petrov National Medical Research Center of Oncology
name: Alexei Barchuk, MD PhD
role: STUDY_CHAIR
References: