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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Petrov Research Institute of Oncology
Sponsor:
Information provided by (Responsible Party):
Petrov Research Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01752647
First received: December 13, 2012
Last updated: December 16, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Procedure: Low dose computed tomography
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Cohort Study of Low Dose Computed Tomography for Lung Cancer Screening in Asymptomatic High-risk Patients.

Resource links provided by NLM:


Further study details as provided by Petrov Research Institute of Oncology:

Primary Outcome Measures:
  • Estimate the time period for recruitment of 500 participants in LDCT screening study. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Lung cancer detection rate [ Time Frame: One year ] [ Designated as safety issue: No ]
    Assess number of lung cancer diagnoses after radiological and morphological verification of positive lung nodules.

  • All-cause mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Assess all-cause mortality mortality within next 5 years.

  • Lung cancer mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Assess lung cancer mortality in the screened group within next 5 years.

  • Nodule detection rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Estimate nodule detection rate, types and sizes of lung nodules found.

  • Recruitment strategies [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Assess the efficacy of different recruitment strategy in this study. Information about the study was shared between general practitioners, radiologists, pulmonologists, thoracic oncologist.


Other Outcome Measures:
  • Comparison of independent radiological evaluation of scans [ Time Frame: One year ] [ Designated as safety issue: No ]
    Comparison of independent radiological evaluation of scans performed by 2 independent specialists.

  • Lung nodules management [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assess algorithms for lung nodules management in regional oncology hospitals in Russian Federation.

  • Frequency of diagnostic procedures. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Estimate the frequency of diagnostic procedures, types of invasive and non-invasive procedures performed.

  • Complication of diagnostic procedures [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Assess the complication rate after diagnostic procedures performed after screening. Procedures include baseline LDCT.

  • Quality of Life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Assess quality of life of patients during screening program.


Estimated Enrollment: 500
Study Start Date: November 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose computed tomography
Patients will have one baseline LDCT scan.
Procedure: Low dose computed tomography
Low dose computed tomography scan
Other Names:
  • CT scan
  • LDCT scan

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

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752647

Contacts
Contact: Anton Barchuk, MD PhD +7 921 946 80 36 barchuk.anton@gmail.com
Contact: Ilja Fomitsev, MD +7 921 416 24 84 i.fomintsev@gmail.com

Locations
Russian Federation
Samara Regional Oncology Dispansery Not yet recruiting
Samara, Samara Region, Russian Federation, 443031
Contact: Denis Bulankin    +7 917 95 95 232    Denis856@bk.ru   
Principal Investigator: Hurmin Vladimir, MD PhD         
Semashko City Clinical Hospital #2 Recruiting
Samara, Samara region, Russian Federation, 443008
Contact: Denis Bulankin    +7 917 95 95 232    Denis856@bk.ru   
Principal Investigator: Hurnin Vladimir, MD PhD         
Sponsors and Collaborators
Petrov Research Institute of Oncology
Investigators
Study Chair: Alexei Barchuk, MD PhD Petrov Research Institute of Oncology
  More Information

No publications provided

Responsible Party: Petrov Research Institute of Oncology
ClinicalTrials.gov Identifier: NCT01752647     History of Changes
Other Study ID Numbers: RLCT-01
Study First Received: December 13, 2012
Last Updated: December 16, 2012
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Petrov Research Institute of Oncology:
lung cancer
screening
low dose
computed tomography

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 01, 2014