Primary Outcome Measures:
- Number of lung cancer cases detected early by spiral CT scan and autofluorescence bronchoscopy [ Designated as safety issue: No ]
- Number of interval lung cancer cases [ Designated as safety issue: No ]
- Stage distribution of lung cancer cases [ Designated as safety issue: No ]
- Prevalence of lung nodules and differences in geographic distribution across Canada [ Designated as safety issue: No ]
- Rate of detection of other incidental significant treatable diseases [ Designated as safety issue: No ]
- 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 [ Designated as safety issue: No ]
- Potential physical and psychosocial impact on participants [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: Yes ]
- Logistics/barriers for an early detection program [ Designated as safety issue: No ]
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.