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

NCT ID: NCT01752647

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 369 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2016-09-30

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Low dose computed tomography

Patients will have one baseline LDCT scan.

Group Type: EXPERIMENTAL

Low dose computed tomography

Intervention Type: PROCEDURE

Low dose computed tomography scan

Interventions

Low dose computed tomography

Low dose computed tomography scan

Intervention Type: PROCEDURE

Other Intervention Names

CT scan; LDCT scan

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

N.N. Petrov National Medical Research Center of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexei Barchuk, MD PhD

Role: STUDY_CHAIR

N.N. Petrov National Medical Research Center of Oncology

Locations

Semashko City Clinical Hospital #2

Samara, Samara Oblast, Russia

Samara Regional Oncology Dispansery

Samara, Samara Oblast, Russia

Countries

Russia

Other Identifiers

RLCT-01

Identifier Type: -

Identifier Source: org_study_id