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

N.N. Petrov National Medical Research Center of Oncology

Status

Completed

Conditions

Lung Cancer

Treatments

Procedure: Low dose computed tomography

Study type

Interventional

Funder types

Other

Identifiers

NCT01752647

RLCT-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

369 patients

Sex

All

Ages

50 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.