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Clinical Trials/NCT00751660
NCT00751660
Unknown
Not Applicable

Early Detection of Lung Cancer - A Pan Canadian Study

British Columbia Cancer Agency6 sites in 1 country2,504 target enrollmentSeptember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
British Columbia Cancer Agency
Enrollment
2504
Locations
6
Primary Endpoint
Number of lung cancer cases detected early by spiral CT scan and autofluorescence bronchoscopy
Last Updated
14 years ago

Overview

Brief Summary

RATIONALE: Screening may help doctors find lung cancer sooner, when it may be easier to treat.

PURPOSE: This clinical trial is studying screening methods to see how well they find lung cancer early in current or former smokers.

Detailed Description

OBJECTIVES: * To develop a new multi-modal screening strategy and integrated methods to detect lung cancer early in current and former smokers. * To evaluate the impact of the screening modalities on the quality of life of these participants. * To develop a decision analytic framework for determining the cost and effectiveness of a novel lung cancer screening strategy in Canada. OUTLINE: This is a multicenter study. Participants undergo spirometry at baseline. Participants also undergo spiral CT scan at baseline and then at 1 and 2 years. Participants with semi-solid or solid nodules of 5-10 mm or ground glass opacity (GGO) 8-10 mm or those with growth of an existing nodule, development of a solid component in GGO, or a new nodule undergo an additional CT scan at 3 months. Some participants also undergo autofluorescence and white light bronchoscopy and bronchial biopsies. Blood samples are collected at baseline and then annually for 2 years for biomarker studies. Participants diagnosed with lung cancer undergo additional blood sample collection for biomarker studies. Participants complete questionnaires on sociodemographic factors, smoking, occupational exposure, family history, medical data, quality of life, and anxiety at baseline and then every 6 months for up to 2 years.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
March 2013
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Number of lung cancer cases detected early by spiral CT scan and autofluorescence bronchoscopy

Time Frame: 24 months

Number of interval lung cancer cases

Time Frame: 60 months

Secondary Outcomes

  • Stage distribution of lung cancer cases(60 months)
  • Prevalence of lung nodules and differences in geographic distribution across Canada(60 months)
  • Rate of detection of other incidental significant treatable diseases(60 months)
  • Type and costs of downstream investigation and treatment related to abnormalities found by the screening procedures, whether the final diagnosis is lung cancer or not(60 months)
  • Potential physical and psychosocial impact on participants(60 months)

Study Sites (6)

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