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    Original Research

    The National Lung Screening Trial: Overview and Study Design

    Published Online:Jan 1 2011https://doi.org/10.1148/radiol.10091808

    Abstract

    The National Lung Screening Trial is a multicenter, randomized controlled trial comparing low-dose helical CT with chest radiography in the screening of current and former heavy smokers for lung cancer.

    The National Lung Screening Trial (NLST) is a randomized multicenter study comparing low-dose helical computed tomography (CT) with chest radiography in the screening of older current and former heavy smokers for early detection of lung cancer, which is the leading cause of cancer-related death in the United States. Five-year survival rates approach 70% with surgical resection of stage IA disease; however, more than 75% of individuals have incurable locally advanced or metastatic disease, the latter having a 5-year survival of less than 5%. It is plausible that treatment should be more effective and the likelihood of death decreased if asymptomatic lung cancer is detected through screening early enough in its preclinical phase. For these reasons, there is intense interest and intuitive appeal in lung cancer screening with low-dose CT. The use of survival as the determinant of screening effectiveness is, however, confounded by the well-described biases of lead time, length, and overdiagnosis. Despite previous attempts, no test has been shown to reduce lung cancer mortality, an endpoint that circumvents screening biases and provides a definitive measure of benefit when assessed in a randomized controlled trial that enables comparison of mortality rates between screened individuals and a control group that does not undergo the screening intervention of interest. The NLST is such a trial. The rationale for and design of the NLST are presented.

    © RSNA, 2010

    Clinical trial registration no. NCT 00047385

    Supplemental material: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.10091808/-/DC1

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    Article History

    Received November 30, 2009; revision requested December 16; revision received June 21, 2010; accepted June 25; final version accepted July 20.
    Published online: Jan 2011
    Published in print: Jan 2011