Screening Methods in Finding Lung Cancer Early in Current or Former Smokers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Detection of Lung Cancer - A Pan Canadian Study

Conditions
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Lung Cancer, Tobacco Use Disorder

Intervention / Treatment
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* Other: laboratory biomarker analysis
* Other: screening questionnaire administration
* Procedure: bronchoscopic and lung imaging studies
* Procedure: computed tomography
* Procedure: endoscopic biopsy
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Current or former smoker A former smoker is defined as one who has stopped smoking ≥ 1 year but < 15 years ago Estimated 1-year lung cancer risk ≥ 1% PATIENT CHARACTERISTICS: ECOG performance status 0-1 Not pregnant Willing to undergo a spiral chest CT scan No severe heart disease (e.g., unstable angina or chronic congestive heart failure) No acute or chronic respiratory failure No bleeding disorder No other medical condition that, in the opinion of the investigator, would preclude the participant's safety during study participation or that would unlikely benefit the participant from screening due to shortened life expectancy from the co-morbidity No diagnosis of cancer, except for any of the following that were previously treated ≥ 5 years ago: Non-melanomatous skin cancer Localized prostate cancer Carcinoma in situ of the cervix Superficial bladder cancer No known reaction to xylocaine, salbutamol, midazolam, or alfentanil PRIOR CONCURRENT THERAPY: More than 2 years since prior chest CT scan No concurrent anti-coagulant treatment (e.g., warfarin or heparin)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: laboratory biomarker analysis|nan|
|Other: screening questionnaire administration|nan|
|Procedure: bronchoscopic and lung imaging studies|nan|
|Procedure: computed tomography|nan|
|Procedure: endoscopic biopsy|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of lung cancer cases detected early by spiral CT scan and autofluorescence bronchoscopy |  | 24 months | 
| Number of interval lung cancer cases |  | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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small cell lung cancer, non-small cell lung cancer, tobacco use disorder