RATIONALE: Effective screening tests should help doctors detect lung cancer early and plan curative treatment. It is not yet known whether low-dose helical computed tomography (LDCT) screening is more effective than chest radiography (CXR) screening in reducing death from lung cancer. PURPOSE: Randomized clinical trial to compare the effectiveness of LDCT scan with that of CXR in screening individuals who are at high risk for developing lung cancer.
OBJECTIVES: * Compare whether screening with low-dose helical CT scan vs chest x-ray reduces lung cancer-specific mortality in participants who are at high risk for developing lung cancer. OUTLINE: NLST participants were randomized to either low-dose helical CT or chest x-ray in equal proportions. A total of 53,454 participants were enrolled (26,722 in low-dose CT and 26,732 in chest radiography) at 33 screening centers across the United States. Screening was offered three times (at baseline and two annual follow-up examinations). The primary endpoint of the study was lung cancer mortality. The study arms were compared with regard to overall mortality, lung cancer incidence, and screening-related complications. All low-dose scanners and chest x-ray machines were certified for use and met NLST protocol requirements and American College of Radiology guidelines. Low-dose CT acquisitions and chest radiographs were interpreted by trained radiologists. Participants and their health care provider were informed of study examination results. Participants with abnormalities suspicious for lung cancer were contacted for information regarding diagnostic evaluation. Medical records were collected on diagnostic evaluation, medical complications, and initial treatment. Participants were then contacted at least annually by mail or telephone. The National Lung Screening Trial (NLST) represents the union of two NCI-sponsored efforts, the NCI Lung Screening Study and the American College of Radiology Imaging Network (ACRIN).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
53,454
A LDCT is a computerized tomography image with low-dose technique without contrast. The scan is done from the neck to the diaphragm in one breath-hold.
The chest x-ray in this study was a single posterior-anterior film done with the participant upright.
Lung Cancer Deaths
Lung cancer deaths confirmed in participants by Endpoint Verification if available, otherwise by death certificate.
Time frame: All events through December 31, 2009; median follow-up 6.5 years.
Deaths From All Causes in All Randomized Participants.
Deaths from all causes were compared between the low-dose CT group and the chest radiography group among all randomized participants.
Time frame: All events through December 31, 2009; median follow-up 6.5 years.
Lung Cancer Diagnoses
Lung cancer diagnoses confirmed by medical record abstraction.
Time frame: All events through December 31, 2009; median follow-up 6.5 years
Complications of Diagnostic Evaluation Following a Positive Screening Test.
Number of participants who experienced complications during diagnostic work-up of a screening CT or CXR that was suspicious for lung cancer.
Time frame: One year from screening examination
T0 (Baseline) Screening Results
Results of radiologist's interpretation of images from LDCT or CXR screening exam at T0.
Time frame: T0 (at study entry)
T1 Screening Results
Results of radiologist's interpretation of images from LDCT or CXR screening exam at T1. Includes a comparison with images from T0 screen.
Time frame: T1 (one year after entry)
T2 Screening Results
Results of radiologist's interpretation of images from LDCT or CXR screening exam at T2. Includes a comparison with images from T0 and T1 screens.
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Univeristy of California, San Diego
La Jolla, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
University of Colorado Denver
Denver, Colorado, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Mayo Clinic
Jacksonville, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Pacific Health Research & Education Institute
Honolulu, Hawaii, United States
Northwestern University
Chicago, Illinois, United States
...and 23 more locations
Time frame: T2 (two years after entry)