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National Lung Screening Trial A Randomized Trial Comparing Low-dose Helical CT With Chest Xray for Lung Cancer
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).
Age
55 - 74 years
Sex
ALL
Healthy Volunteers
Yes
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
Start Date
August 1, 2002
Primary Completion Date
October 1, 2010
Completion Date
October 1, 2010
Last Updated
May 20, 2014
53,454
ACTUAL participants
low-dose helical computed tomography
DEVICE
chest radiography
DEVICE
Lead Sponsor
National Cancer Institute (NCI)
Collaborators
NCT05198830
NCT07336732
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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