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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752647
• Other study ID #: RLCT-01
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: September 2016

Study information

• Verified date: September 2019
• Source: N.N. Petrov National Medical Research Center of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 369
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• Low dose computed tomography
Low dose computed tomography scan

Locations

Country	Name	City	State
Russian Federation	Samara Regional Oncology Dispansery	Samara	Samara Region
Russian Federation	Semashko City Clinical Hospital #2	Samara	Samara Region

Sponsors (1)

Lead Sponsor	Collaborator
N.N. Petrov National Medical Research Center of Oncology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of independent radiological evaluation of scans	Comparison of independent radiological evaluation of scans performed by 2 independent specialists.	One year
Other	Lung nodules management	Assess algorithms for lung nodules management in regional oncology hospitals in Russian Federation.	12 months
Other	Frequency of diagnostic procedures.	Estimate the frequency of diagnostic procedures, types of invasive and non-invasive procedures performed.	12 months
Other	Complication of diagnostic procedures	Assess the complication rate after diagnostic procedures performed after screening. Procedures include baseline LDCT.	12 months
Primary	Estimate the time period for recruitment of 500 participants in LDCT screening study.	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.	3 months
Secondary	Lung cancer detection rate	Assess number of lung cancer diagnoses after radiological and morphological verification of positive lung nodules.	One year
Secondary	All-cause mortality	Assess all-cause mortality mortality within next 5 years.	5 years
Secondary	Lung cancer mortality	Assess lung cancer mortality in the screened group within next 5 years.	5 years
Secondary	Nodule detection rate	Estimate nodule detection rate, types and sizes of lung nodules found.	3 months
Secondary	Recruitment strategies	Assess the efficacy of different recruitment strategy in this study. Information about the study was shared between general practitioners, radiologists, pulmonologists, thoracic oncologist.	3 months