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

December 13, 2012
December 16, 2012
November 2012
February 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01752647 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
  • 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.
Same as current
 
CT Screening For Lung Cancer in High Risk Patients: the Russian Study.
Cohort Study of Low Dose Computed Tomography for Lung Cancer Screening in Asymptomatic High-risk Patients.

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.

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.
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Lung Cancer
Procedure: Low dose computed tomography
Low dose computed tomography scan
Other Names:
  • CT scan
  • LDCT scan
Experimental: Low dose computed tomography
Patients will have one baseline LDCT scan.
Intervention: Procedure: Low dose computed tomography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
March 2013
February 2013   (final data collection date for primary outcome measure)

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.
Both
50 Years to 75 Years
Yes
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
Russian Federation
 
NCT01752647
RLCT-01
No
Petrov Research Institute of Oncology
Petrov Research Institute of Oncology
Not Provided
Study Chair: Alexei Barchuk, MD PhD Petrov Research Institute of Oncology
Petrov Research Institute of Oncology
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP