National Lung Screening Trialの概要と評価

The National Lung Screening Trial (NLST) was a randomized controlled clinical trial of screening tests for lung cancer. Approximately 54,000 participants were enrolled between August 2002 and April 2004. Participants were randomly assigned to two study arms in equal proportions. One arm received low-dose helical computed tomography (CT), while the other received single-view chest radiography. Participants were offered three exams (T0, T1, and T2) at one-year intervals, with the first (T0) performed soon after entry. The goal of the study was to assess whether low-dose CT screening reduces lung cancer mortality relative to chest radiography among high-risk individuals. Data were collected on cancer diagnoses and deaths that occurred through December 31, 2009. Median follow-up time was 6.5 years. The number for NLST is ClinicalTrials.gov NCT00047385.NLST was a collaborative effort of the National Cancer Institute's Division of Cancer Prevention (DCP) and Division of Cancer Treatment and Diagnosis (DCTD). DCP funded and administered the Lung Screening Study network (LSS, 10 centers, ~35,000 participants) while DCTD funded and administered the American College of Radiology Imaging Network (ACRIN, 23 centers, ~19,000 participants). The study protocols and data collection forms used by LSS and ACRIN were harmonized. A trial-wide database of harmonized data elements was built during the trial for reporting to the Data and Safety Monitoring Board (DSMB). Some additional data elements were collected only by ACRIN or by LSS, as described in the final section of this document.