Lung CancerPhase 3NLSTNCT00047385
National Lung Screening Trial (NLST) Screening
A Phase 3 study testing low-dose helical computed tomography and chest radiography in people with Lung Cancer, run by National Cancer Institute (NCI) at 33 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- low-dose helical computed tomography and chest radiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53,454 participants
- Where
- 33 sitesUnited States
- Study dates
- Aug 2002to Oct 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 55-74 years (pack-years = packs per day * years smoked)
- 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
Who cannot join
- Metallic implants or devices in the chest or back, such as pacemakers or Harrington fixation rods
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0942
Emory University School of Medicine
Atlanta, Georgia, 30322
Johns Hopkins University
Baltimore, Maryland, 21231
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
University of Colorado Denver
Denver, Colorado, 80262
Henry Ford Health System
Detroit, Michigan, 48202
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, 08690
Pacific Health Research & Education Institute
Honolulu, Hawaii, 96813
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
University of Iowa
Iowa City, Iowa, 52242-1011
Mayo Clinic
Jacksonville, Florida, 32224
Univeristy of California, San Diego
La Jolla, California, 92093-0658
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0002
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Jewish Hopsital Heart and Lung Institute
Louisville, Kentucky, 40202
Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
University of Minnesota School of Public Health
Minneapolis, Minnesota, 55455
Vanderbilt University
Nashville, Tennessee, 37232-6838
Ochsner Medical Foundation Hospital
New Orleans, Louisiana, 70121
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15236
Brown University, Rhode Island Hospital
Providence, Rhode Island, 02908-4735
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
University of Utah Health Sciences Center
Salt Lake City, Utah, 84112
Washington University School of Medicine
St Louis, Missouri, 63108
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Wake Forest University
Winston-Salem, North Carolina, 27106
St Elizabeth Health Center
Youngstown, Ohio, 44504
About this study
Official title: 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.
Read the detailed description
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).
- Conditions
- Lung Cancer
- Being tested
- low-dose helical computed tomography, chest radiography
- Keywords
- small cell lung cancer, non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-dose helical computed tomographyDevice
Also called LDCT
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 radiographyDevice
Also called CXR
The chest x-ray in this study was a single posterior-anterior film done with the participant upright.
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose CT | Experimental | Not described Receives: Device: low-dose helical computed tomography |
| Chest X-ray | Experimental | Not described Receives: Device: chest radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Cancer Deaths
Lung cancer deaths confirmed in participants by Endpoint Verification if available, otherwise by death certificate.
Measured: All events through December 31, 2009; median follow-up 6.5 years.
Secondary outcomes (6)
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.
Measured: All events through December 31, 2009; median follow-up 6.5 years.
Lung Cancer Diagnoses
Lung cancer diagnoses confirmed by medical record abstraction.
Measured: 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.
Measured: One year from screening examination
T0 (Baseline) Screening Results
Results of radiologist's interpretation of images from LDCT or CXR screening exam at T0.
Measured: 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.
Measured: 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.
Measured: T2 (two years after entry)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 2002
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53,454 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- American College of Radiology Imaging Network
- Responsible party
- Sponsor
- Investigators
- Christine D. Berg, MD, Study director, NCI - Early Detection Research GroupDenise R. Aberle, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00047385
- Sponsor's protocol ID
- NCI-2012-02002
- Other IDs
- U01CA079778, U01CA080098, N1CN25476A-85-0-1, NIH/NCI, CDR0000257938
- Acronym
- NLST
- Status last verified
- Oct 2012
- First submitted
- 3 Oct 2002
- Last updated
- 20 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21045183Cody DD, Kim HJ, Cagnon CH, Larke FJ, McNitt-Gray MM, Kruger RL, Flynn MJ, Seibert JA, Judy PF, Wu X. Normalized CT dose index of the CT scanners used in the National Lung Screening Trial. AJR Am J Roentgenol. 2010 Jun;194(6):1539-46. doi: 10.2214/AJR.09.3268.
PubMed 20489094Clark 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.
PubMed 18777192Gierada 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.
PubMed 19620438National 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.
PubMed 21714641Singh S, Pinsky P, Fineberg NS, Gierada DS, Garg K, Sun Y, Nath PH. Evaluation of reader variability in the interpretation of follow-up CT scans at lung cancer screening. Radiology. 2011 Apr;259(1):263-70. doi: 10.1148/radiol.10101254. Epub 2011 Jan 19.
PubMed 21248232National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Clapp JD, Clingan KL, Gareen IF, Lynch DA, Marcus PM, Pinsky PF. Baseline characteristics of participants in the randomized national lung screening trial. J Natl Cancer Inst. 2010 Dec 1;102(23):1771-9. doi: 10.1093/jnci/djq434. Epub 2010 Nov 22.
PubMed 21119104Park 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.
PubMed 19711141Gierada 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.
PubMed 18024436Fan Y, Wang Y, Li X, Wu H, Pan H, Jiang Y, Meng Z, Wang J, Chen J, Zhou Q, Qiao Y. Stage shift, histological differentiation, and survival patterns of lung squamous cell carcinoma versus adenocarcinoma in low-dose CT screening. Cancer Epidemiol. 2026 Aug 11;104:103197. doi: 10.1016/j.canep.2026.103197. Online ahead of print.
PubMed 42580153Langenbach IL, Hadzic I, Zeleznik R, Langenbach MC, Maintz D, Mayrhofer T, Lu MT, Aerts HJWL, Foldyna B. Association of Epicardial Adipose Tissue Changes on Serial Chest CT Scans with Mortality: Insights from the National Lung Screening Trial. Radiology. 2025 Feb;314(2):e240473. doi: 10.1148/radiol.240473.
PubMed 39964263Zhong D, Sidorenkov G, Jacobs C, de Jong PA, Gietema HA, Stadhouders R, Nackaerts K, Aerts JG, Prokop M, Groen HJM, de Bock GH, Vliegenthart R, Heuvelmans MA. Lung Nodule Management in Low-Dose CT Screening for Lung Cancer: Lessons from the NELSON Trial. Radiology. 2024 Oct;313(1):e240535. doi: 10.1148/radiol.240535.
PubMed 39436294Marcinkiewicz 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.
PubMed 39287522Venkadesh 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.
PubMed 37526548Xu 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.
PubMed 37489991
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Lung Screening Trial A Randomized Trial Comparing Low-dose Helical CT With Chest Xray for Lung Cancer
- ClinicalTrials.gov ID
- NCT00047385
- Acronym / sponsor ID
- NLST / NCI-2012-02002
- Conditions
- Lung Cancer
- Keywords
- small cell lung cancer, non-small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53,454 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- American College of Radiology Imaging Network
- Study start
- Aug 2002
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Posted 6 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Dose CT | Experimental | Device: low-dose helical computed tomography |
| Chest X-ray | Experimental | Device: chest radiography |
Who may qualify
- Ages
- 55 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 55-74 years (pack-years = packs per day * years smoked)
- 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
Key exclusion criteria (11 listed)
- Metallic implants or devices in the chest or back, such as pacemakers or Harrington fixation rods
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-dose helical computed tomographyAlso: LDCTA 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. | Device | Low-Dose CT |
| chest radiographyAlso: CXRThe chest x-ray in this study was a single posterior-anterior film done with the participant upright. | Device | Chest X-ray |
Primary outcome
Lung Cancer Deaths
Time frame: All events through December 31, 2009; median follow-up 6.5 years.
Lung cancer deaths confirmed in participants by Endpoint Verification if available, otherwise by death certificate.
6 secondary outcomes
Deaths From All Causes in All Randomized Participants.
Time frame: All events through December 31, 2009; median follow-up 6.5 years.
Lung Cancer Diagnoses
Time frame: All events through December 31, 2009; median follow-up 6.5 years
Complications of Diagnostic Evaluation Following a Positive Screening Test.
Time frame: One year from screening examination
T0 (Baseline) Screening Results
Time frame: T0 (at study entry)
T1 Screening Results
Time frame: T1 (one year after entry)
T2 Screening Results
Time frame: T2 (two years after entry)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21045183National 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.
- Background: PubMed 20489094Cody DD, Kim HJ, Cagnon CH, Larke FJ, McNitt-Gray MM, Kruger RL, Flynn MJ, Seibert JA, Judy PF, Wu X. Normalized CT dose index of the CT scanners used in the National Lung Screening Trial. AJR Am J Roentgenol. 2010 Jun;194(6):1539-46. doi: 10.2214/AJR.09.3268.
- Background: PubMed 18777192Clark 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.
- Background: PubMed 19620438Gierada 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.
- Results publication: PubMed 21714641National 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.
- Results publication: PubMed 21248232Singh S, Pinsky P, Fineberg NS, Gierada DS, Garg K, Sun Y, Nath PH. Evaluation of reader variability in the interpretation of follow-up CT scans at lung cancer screening. Radiology. 2011 Apr;259(1):263-70. doi: 10.1148/radiol.10101254. Epub 2011 Jan 19.
- Results publication: PubMed 21119104National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Clapp JD, Clingan KL, Gareen IF, Lynch DA, Marcus PM, Pinsky PF. Baseline characteristics of participants in the randomized national lung screening trial. J Natl Cancer Inst. 2010 Dec 1;102(23):1771-9. doi: 10.1093/jnci/djq434. Epub 2010 Nov 22.
- Results publication: PubMed 19711141Park 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.
- Results publication: PubMed 18024436Gierada 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.
- Derived from this study: PubMed 42580153Fan Y, Wang Y, Li X, Wu H, Pan H, Jiang Y, Meng Z, Wang J, Chen J, Zhou Q, Qiao Y. Stage shift, histological differentiation, and survival patterns of lung squamous cell carcinoma versus adenocarcinoma in low-dose CT screening. Cancer Epidemiol. 2026 Aug 11;104:103197. doi: 10.1016/j.canep.2026.103197. Online ahead of print.
- Derived from this study: PubMed 39964263Langenbach IL, Hadzic I, Zeleznik R, Langenbach MC, Maintz D, Mayrhofer T, Lu MT, Aerts HJWL, Foldyna B. Association of Epicardial Adipose Tissue Changes on Serial Chest CT Scans with Mortality: Insights from the National Lung Screening Trial. Radiology. 2025 Feb;314(2):e240473. doi: 10.1148/radiol.240473.
- Derived from this study: PubMed 39436294Zhong D, Sidorenkov G, Jacobs C, de Jong PA, Gietema HA, Stadhouders R, Nackaerts K, Aerts JG, Prokop M, Groen HJM, de Bock GH, Vliegenthart R, Heuvelmans MA. Lung Nodule Management in Low-Dose CT Screening for Lung Cancer: Lessons from the NELSON Trial. Radiology. 2024 Oct;313(1):e240535. doi: 10.1148/radiol.240535.
- Web site for additional informationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine D. Berg, MD study director
NCI - Early Detection Research Group
Denise R. Aberle, MD principal investigator
Jonsson Comprehensive Cancer Center
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing low-dose helical computed tomography and chest radiography in people with Lung Cancer, run by National Cancer Institute (NCI) at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Cancer Deaths (time frame: All events through December 31, 2009; median follow-up 6.5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00047385, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.