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Protocol and Rationale for the International Lung Screening Trial.
Kuan Pin Lim1,2, Henry Marshall3, Martin Tammemägi4
1Department of Respiratory Medicine, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.
Annals of the American Thoracic Society
|February 4, 2020
Summary
The International Lung Screening Trial (ILST) compares risk models for lung cancer screening. It evaluates the PLCOm2012 and PanCan models to improve early detection and nodule management efficiency.
Area of Science:
- Oncology
- Radiology
- Preventive Medicine
Background:
- Low-dose computed tomography (LDCT) screening reduces lung cancer mortality, but optimizing screenee selection and nodule management remains crucial.
- Validated risk models like PLCOm2012 (Prostate, Lung, Colorectal and Ovarian) and PanCan (Pan-Canadian Early Detection of Lung Cancer) offer potential improvements.
- Integrating these models may enhance lung cancer screening efficiency.
Purpose of the Study:
- To compare the accuracy of the PLCOm2012 model against U.S. Preventive Services Task Force (USPSTF) criteria for detecting lung cancers.
- To evaluate the efficiency of nodule management using the PanCan probability calculator-based protocol versus Lung-RADS.
- To prospectively assess the comparative accuracy and effectiveness of these risk models in lung cancer screening.
Main Methods:
- The International Lung Screening Trial (ILST) will recruit 4,500 participants meeting USPSTF and/or PLCOm2012 risk criteria.
- Participants undergo baseline and 2-year LDCT screening, with nodules managed by the PanCan probability score.
- Follow-up is for a minimum of 5 years, with primary outcomes focused on cancer detection rates and management group distributions.
Main Results:
- Primary outcomes for aim 1 include the proportion of individuals selected, lung cancers detected, and positive predictive values for each selection criterion.
- Outcomes for aim 2 compare distributions of individuals and lung cancer proportions across surveillance, early recall, and diagnostic evaluation groups.
- Statistical power to detect differences in primary study aims is ≥82%.
Conclusions:
- The ILST will provide prospective data on the comparative accuracy of PLCOm2012 and USPSTF criteria for lung cancer screening.
- The study will evaluate the efficiency of PanCan-based nodule management compared to Lung-RADS.
- Findings will inform optimized lung cancer screening strategies using validated risk prediction models.
