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| Name | Class |
|---|---|
| Alberta Cancer Foundation | OTHER |
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Lung cancer is the leading cause of cancer death in North America and in the world. The vast majority of lung cancers are associated with cigarette smoking. Unfortunately, the majority of lung cancers are detected at an advanced stage when they have a very poor prognosis. A substantial amount of data has been reported on low-dose computed tomography (LDCT) screening. Yet endorsement of lung cancer screening has not been universal because of outstanding concerns which need to be addressed. Our study will aim to screen at risk Albertans for lung cancer with LDCT scan at baseline, year 1 and year 2 while attempting to fill some knowledge gaps on this topic.
Lung cancer is the leading cause of cancer death in North America and in the world. The vast majority of lung cancers are associated with cigarette smoking. Lung cancer incidence and mortality rates are similar because lung cancer is a highly fatal disease. Unfortunately, the majority of lung cancers are detected at an advanced stage when they have a very poor prognosis. A substantial amount of data has been reported on low-dose computed tomography (LDCT) screening. The results of the National Lung Screening Trial (NLST) showed a 20% reduction in mortality from lung cancer with LDCT screening in addition to a 6.7% decrease in all-cause mortality, the first ever screening intervention to demonstrate an improvement in this latter outcome. Yet endorsement of lung cancer screening has not been universal. Although the NLST results are encouraging, more investigation is needed.
The objectives of this study are to prospectively compare the performance of a lung cancer risk prediction model (RPM) vs. NLST criteria to inform optimal inclusion criteria for a clinical screening program; to prospectively compare a novel screening based nodule malignancy probability calculation which has been developed in the Pan-Canadian Early Detection of Lung Cancer study vs. NLST criteria; to complete a randomized controlled trial as a substudy comparing an intensive tobacco cessation counseling program to a usual care arm for subjects with ongoing tobacco use; to perform a cost analysis evaluating the incremental costs associated with LDCT screening for lung cancer compared to no screening; to determine the average cost associated with incidental findings, false positive findings and lung cancers found during the screening period; and to compare cost implications of both screening enrollment criteria.
The backbone of this research project will be the screening of at risk individuals for lung cancer with LDCT scan. Eight hundred at risk Albertans will be screened at baseline, year 1 and year 2. Additional clinical LDCT or other investigations may result from findings on the study CT scans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening arm | Experimental | Annual low dose screening chest CT scan x 3. |
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| Smoking cessation counseling | Experimental | Active smokers randomized to this arm will be contacted by a trained smoking cessation counselor and offered cessation support and advice. |
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| Smoking cessation control | Active Comparator | Active smokers randomized to this arm will receive general information on available smoking cessation resources. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Low dose chest CT screening annually x 3 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of screening enrollment criteria (Risk prediction model (RPM) vs. NLST criteria) | The proportion of individuals selected by RPM or NLST will be calculated as the number of subjects qualifying and consenting to the screening intervention / total number of subjects enrolled with either criteria. Superiority of the risk prediction model over NLST criteria will be considered established if it identifies at least as many cases of lung cancer as the NLST while sampling fewer individuals. | 5 years |
| Randomized trial of smoking cessation intervention in screened individuals (smoking status [smoking rates assessed via questionnaire and abstinence confirmed by saliva nicotine or exhaled carbon minoxide]) | The primary study endpoint will be an assessment of smoking status at 12 months following randomization. Smoking rates will be assessed via phone questionnaire and abstinence confirmed by saliva nicotine test or exhaled carbon monoxide in subjects using nicotine replacement therapies (to avoid false positive nicotine test). | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of nodule risk calculator | We will prospectively validate a nodule risk calculator by comparing the proportion of baseline CT examinations reported as positive by the calculator vs. NLST criteria on a per subject basis | 3 years |
| Health Economics Analysis (healthcare payer and all direct health-care related cost) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alain Tremblay, MD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N4N1 | Canada | ||
| University of Alberta |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34589978 | Derived | Tremblay A, Taghizadeh N, MacEachern P, Burrowes P, Graham AJ, Lam SC, Yang H, Koetzler R, Tammemagi MC, Taylor K, Bedard ELR. Two-Year Follow-Up of a Randomized Controlled Study of Integrated Smoking Cessation in a Lung Cancer Screening Program. JTO Clin Res Rep. 2020 Sep 15;2(2):100097. doi: 10.1016/j.jtocrr.2020.100097. eCollection 2021 Feb. | |
| 31077790 |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| ID | Term |
|---|---|
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
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| Active smokers - Smoking cessation arm |
| Behavioral |
Phone based smoking cessation counseling |
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| Active smokers - Control arm | Behavioral | Subjects will be provided with general information on available smoking cessation resources |
|
Costs will be estimated for the cohort of individuals who enroll in the screening program and consent to receive a LDCT scan. Costs will also be estimated for a group of individuals who are eligible for the screening program however do not undergo screening. We will include costs for all relevant health care categories for a 2 year period from the date of risk stratification. The perspective of the analysis will be that of the healthcare payer and all direct health-care related costs would be captured and reported in Canadian dollars. |
| 4 years |
| Edmonton |
| Alberta |
| Canada |
| Tremblay A, Taghizadeh N, Huang J, Kasowski D, MacEachern P, Burrowes P, Graham AJ, Dickinson JA, Lam SC, Yang H, Koetzler R, Tammemagi M, Taylor K, Bedard ELR. A Randomized Controlled Study of Integrated Smoking Cessation in a Lung Cancer Screening Program. J Thorac Oncol. 2019 Sep;14(9):1528-1537. doi: 10.1016/j.jtho.2019.04.024. Epub 2019 May 8. |
| D012140 |
| Respiratory Tract Diseases |