Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
53454 participants
INTERVENTIONAL
2002-08-31
2010-10-31
Brief Summary
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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.
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Detailed Description
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* 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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Low-Dose CT
low-dose helical computed tomography
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.
Chest X-ray
chest radiography
The chest x-ray in this study was a single posterior-anterior film done with the participant upright.
Interventions
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low-dose helical computed tomography
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.
chest radiography
The chest x-ray in this study was a single posterior-anterior film done with the participant upright.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 30 or more pack-years of cigarette smoking history
* Former smokers: quit smoking within the previous 15 years
* Ability to lie on the back with arms raised over the head
* Signed informed consent form
Exclusion Criteria
* Treatment for, or evidence of, any cancer other than nonmelanoma skin cancer or carcinoma in situ (with the exception of transitional cell carcinoma in situ or bladder carcinoma in situ) in the 5 years prior to eligibility assessment
* History of lung cancer
* History of removal of any portion of the lung, excluding needle biopsy
* Requirement for home oxygen supplementation
* Participation in another cancer screening trial
* Participation in a cancer prevention study, other than a smoking cessation study
* Unexplained weight loss of more than 15 pounds in the 12 months prior to eligibility assessment
* Recent hemoptysis
* Pneumonia or acute respiratory infection treated with antibiotics in the 12 weeks prior to eligibility assessment
* Chest CT examination in the 18 months prior to eligibility assessment
55 Years
74 Years
ALL
Yes
Sponsors
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American College of Radiology Imaging Network
NETWORK
National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Christine D. Berg, MD
Role: STUDY_DIRECTOR
NCI - Early Detection Research Group
Denise R. Aberle, MD
Role: PRINCIPAL_INVESTIGATOR
Jonsson Comprehensive Cancer Center
Locations
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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
University of Iowa
Iowa City, Iowa, United States
Jewish Hopsital Heart and Lung Institute
Louisville, Kentucky, United States
Ochsner Medical Foundation Hospital
New Orleans, Louisiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Minnesota School of Public Health
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States
Wake Forest University
Winston-Salem, North Carolina, United States
St Elizabeth Health Center
Youngstown, Ohio, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Brown University, Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
Countries
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References
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National Lung Screening Trial Research Team; Aberle DR, Berg CD, Black WC, Church TR, Fagerstrom RM, Galen B, Gareen IF, Gatsonis C, Goldin J, Gohagan JK, Hillman B, Jaffe C, Kramer BS, Lynch D, Marcus PM, Schnall M, Sullivan DC, Sullivan D, Zylak CJ. The National Lung Screening Trial: overview and study design. Radiology. 2011 Jan;258(1):243-53. doi: 10.1148/radiol.10091808. Epub 2010 Nov 2.
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Clark KW, Gierada DS, Marquez G, Moore SM, Maffitt DR, Moulton JD, Wolfsberger MA, Koppel P, Phillips SR, Prior FW. Collecting 48,000 CT exams for the lung screening study of the National Lung Screening Trial. J Digit Imaging. 2009 Dec;22(6):667-80. doi: 10.1007/s10278-008-9145-9. Epub 2008 Sep 6.
Gierada DS, Garg K, Nath H, Strollo DC, Fagerstrom RM, Ford MB. CT quality assurance in the lung screening study component of the National Lung Screening Trial: implications for multicenter imaging trials. AJR Am J Roentgenol. 2009 Aug;193(2):419-24. doi: 10.2214/AJR.08.1995.
National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
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Park ER, Ostroff JS, Rakowski W, Gareen IF, Diefenbach MA, Feibelmann S, Rigotti NA. Risk perceptions among participants undergoing lung cancer screening: baseline results from the National Lung Screening Trial. Ann Behav Med. 2009 Jun;37(3):268-79. doi: 10.1007/s12160-009-9112-9. Epub 2009 Aug 27.
Gierada DS, Pilgram TK, Ford M, Fagerstrom RM, Church TR, Nath H, Garg K, Strollo DC. Lung cancer: interobserver agreement on interpretation of pulmonary findings at low-dose CT screening. Radiology. 2008 Jan;246(1):265-72. doi: 10.1148/radiol.2461062097. Epub 2007 Nov 16.
Marcinkiewicz AM, Buchwald M, Shanbhag A, Bednarski BP, Killekar A, Miller RJH, Builoff V, Lemley M, Berman DS, Dey D, Slomka PJ. AI for Multistructure Incidental Findings and Mortality Prediction at Chest CT in Lung Cancer Screening. Radiology. 2024 Sep;312(3):e240541. doi: 10.1148/radiol.240541.
Venkadesh KV, Aleef TA, Scholten ET, Saghir Z, Silva M, Sverzellati N, Pastorino U, van Ginneken B, Prokop M, Jacobs C. Prior CT Improves Deep Learning for Malignancy Risk Estimation of Screening-detected Pulmonary Nodules. Radiology. 2023 Aug;308(2):e223308. doi: 10.1148/radiol.223308.
Xu K, Khan MS, Li TZ, Gao R, Terry JG, Huo Y, Lasko TA, Carr JJ, Maldonado F, Landman BA, Sandler KL. AI Body Composition in Lung Cancer Screening: Added Value Beyond Lung Cancer Detection. Radiology. 2023 Jul;308(1):e222937. doi: 10.1148/radiol.222937.
Kinsey CM, Billatos E, Mori V, Tonelli B, Cole BF, Duan F, Marques H, de la Bruere I, Onieva J, San Jose Estepar R, Cleveland A, Idelkope D, Stevenson C, Bates JHT, Aberle D, Spira A, Washko G, San Jose Estepar R. A simple assessment of lung nodule location for reduction in unnecessary invasive procedures. J Thorac Dis. 2021 Jul;13(7):4207-4216. doi: 10.21037/jtd-20-3093.
Tammemagi MC, Ten Haaf K, Toumazis I, Kong CY, Han SS, Jeon J, Commins J, Riley T, Meza R. Development and Validation of a Multivariable Lung Cancer Risk Prediction Model That Includes Low-Dose Computed Tomography Screening Results: A Secondary Analysis of Data From the National Lung Screening Trial. JAMA Netw Open. 2019 Mar 1;2(3):e190204. doi: 10.1001/jamanetworkopen.2019.0204.
Wong JYY, Bassig BA, Seow WJ, Hu W, Ji BT, Blair A, Silverman DT, Lan Q. Lung cancer risk in welders and foundry workers with a history of heavy smoking in the USA: The National Lung Screening Trial. Occup Environ Med. 2017 Jun;74(6):440-448. doi: 10.1136/oemed-2016-104168. Epub 2017 Jan 9.
Patz EF Jr, Greco E, Gatsonis C, Pinsky P, Kramer BS, Aberle DR. Lung cancer incidence and mortality in National Lung Screening Trial participants who underwent low-dose CT prevalence screening: a retrospective cohort analysis of a randomised, multicentre, diagnostic screening trial. Lancet Oncol. 2016 May;17(5):590-9. doi: 10.1016/S1470-2045(15)00621-X. Epub 2016 Mar 18.
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Tanner NT, Gebregziabher M, Hughes Halbert C, Payne E, Egede LE, Silvestri GA. Racial Differences in Outcomes within the National Lung Screening Trial. Implications for Widespread Implementation. Am J Respir Crit Care Med. 2015 Jul 15;192(2):200-8. doi: 10.1164/rccm.201502-0259OC.
Clark MA, Gorelick JJ, Sicks JD, Park ER, Graham AL, Abrams DB, Gareen IF. The Relations Between False Positive and Negative Screens and Smoking Cessation and Relapse in the National Lung Screening Trial: Implications for Public Health. Nicotine Tob Res. 2016 Jan;18(1):17-24. doi: 10.1093/ntr/ntv037. Epub 2015 Mar 6.
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Black WC, Gareen IF, Soneji SS, Sicks JD, Keeler EB, Aberle DR, Naeim A, Church TR, Silvestri GA, Gorelick J, Gatsonis C; National Lung Screening Trial Research Team. Cost-effectiveness of CT screening in the National Lung Screening Trial. N Engl J Med. 2014 Nov 6;371(19):1793-802. doi: 10.1056/NEJMoa1312547.
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National Lung Screening Trial Research Team; Church TR, Black WC, Aberle DR, Berg CD, Clingan KL, Duan F, Fagerstrom RM, Gareen IF, Gierada DS, Jones GC, Mahon I, Marcus PM, Sicks JD, Jain A, Baum S. Results of initial low-dose computed tomographic screening for lung cancer. N Engl J Med. 2013 May 23;368(21):1980-91. doi: 10.1056/NEJMoa1209120.
Singh SP, Gierada DS, Pinsky P, Sanders C, Fineberg N, Sun Y, Lynch D, Nath H. Reader variability in identifying pulmonary nodules on chest radiographs from the national lung screening trial. J Thorac Imaging. 2012 Jul;27(4):249-54. doi: 10.1097/RTI.0b013e318256951e.
Matsuoka S, Washko GR, Dransfield MT, Yamashiro T, San Jose Estepar R, Diaz A, Silverman EK, Patz S, Hatabu H. Quantitative CT measurement of cross-sectional area of small pulmonary vessel in COPD: correlations with emphysema and airflow limitation. Acad Radiol. 2010 Jan;17(1):93-9. doi: 10.1016/j.acra.2009.07.022. Epub 2009 Sep 30.
Dransfield MT, Washko GR, Foreman MG, Estepar RS, Reilly J, Bailey WC. Gender differences in the severity of CT emphysema in COPD. Chest. 2007 Aug;132(2):464-70. doi: 10.1378/chest.07-0863. Epub 2007 Jun 15.
Related Links
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Web site for additional information
Other Identifiers
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NIH/NCI
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000257938
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-02002
Identifier Type: -
Identifier Source: org_study_id
NCT00028808
Identifier Type: -
Identifier Source: nct_alias
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