NCT01752647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
369

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 13, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 19, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

3.8 years

First QC Date

December 13, 2012

Last Update Submit

September 2, 2019

Conditions

Lung Cancer

Keywords

lung cancerscreeninglow dosecomputed tomography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Lung cancer detection rate

    One year

  • All-cause mortality

    5 years

  • Lung cancer mortality

    5 years

  • Nodule detection rate

    3 months

  • Recruitment strategies

    3 months

Other Outcomes (4)

  • Comparison of independent radiological evaluation of scans

    One year

  • Lung nodules management

    12 months

  • Frequency of diagnostic procedures.

    12 months

  • +1 more other outcomes

Study Arms (1)

Low dose computed tomography

EXPERIMENTAL

Patients will have one baseline LDCT scan.

Procedure: Low dose computed tomography

Interventions

Low dose computed tomographyPROCEDURE

Low dose computed tomography scan

Also known as: CT scan, LDCT scan
Low dose computed tomography

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50-75 years
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Semashko City Clinical Hospital #2

Samara, Samara Oblast, 443008, Russia

Location

Samara Regional Oncology Dispansery

Samara, Samara Oblast, 443031, Russia

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Alexei Barchuk, MD PhD

    N.N. Petrov National Medical Research Center of Oncology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2012

First Posted

December 19, 2012

Study Start

November 1, 2012

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 4, 2019

Record last verified: 2019-09

Locations

RU(2)