National Lung Screening Trial (NLST) Screening

NCT00047385 | Completed Phase 3 Results DMC

• 6 other identifiers: NCI-2012-02002U01CA079778U01CA080098N1CN25476A-85-0-1NIH/NCICDR0000257938
• Study Type: interventional
• Target: 53,454
• Locations: 1 country
• Sites: 33

Brief 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. 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.

Conditions

Lung Cancer

Keywords

small cell lung cancer; non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Lung Cancer Deaths

  Lung cancer deaths confirmed in participants by Endpoint Verification if available, otherwise by death certificate.

  All events through December 31, 2009; median follow-up 6.5 years.

Secondary Outcomes (6)

• Deaths From All Causes in All Randomized Participants.

  All events through December 31, 2009; median follow-up 6.5 years.

• Lung Cancer Diagnoses

  All events through December 31, 2009; median follow-up 6.5 years

• Complications of Diagnostic Evaluation Following a Positive Screening Test.

  One year from screening examination

• T0 (Baseline) Screening Results

  T0 (at study entry)

• T1 Screening Results

  T1 (one year after entry)

Study Arms (2)

Low-Dose CT

EXPERIMENTAL

Device: low-dose helical computed tomography

Chest X-ray

EXPERIMENTAL

Device: chest radiography

Interventions

low-dose helical computed tomography DEVICE

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.

Also known as: LDCT

Low-Dose CT

chest radiography DEVICE

The chest x-ray in this study was a single posterior-anterior film done with the participant upright.

Also known as: CXR

Chest X-ray

Eligibility Criteria

• Age: 55 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55-74 years (pack-years = packs per day \* years smoked)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• American College of Radiology Imaging Network: collaborator

Study Sites (33)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Univeristy of California, San Diego

La Jolla, California, 92093-0658, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

University of Colorado Denver

Denver, Colorado, 80262, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Pacific Health Research & Education Institute

Honolulu, Hawaii, 96813, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Iowa

Iowa City, Iowa, 52242-1011, United States

Location

Jewish Hopsital Heart and Lung Institute

Louisville, Kentucky, 40202, United States

Location

Ochsner Medical Foundation Hospital

New Orleans, Louisiana, 70121, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21231, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

University of Minnesota School of Public Health

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey, 08690, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27106, United States

Location

St Elizabeth Health Center

Youngstown, Ohio, 44504, United States

Location

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15236, United States

Location

Brown University, Rhode Island Hospital

Providence, Rhode Island, 02908-4735, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232-6838, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84112, United States

Location

Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Related Publications (28)

• 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.

  PMID: 21045183 BACKGROUND

• Cody 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.

  PMID: 20489094 BACKGROUND

• 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.

  PMID: 18777192 BACKGROUND

• 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.

  PMID: 19620438 BACKGROUND

• 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.

  PMID: 21714641 RESULT

• Singh 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.

  PMID: 21248232 RESULT

• National 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.

  PMID: 21119104 RESULT

• 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.

  PMID: 19711141 RESULT

• 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.

  PMID: 18024436 RESULT

• 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.

  PMID: 39287522 DERIVED

• 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.

  PMID: 37526548 DERIVED

• 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.

  PMID: 37489991 DERIVED

• 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.

  PMID: 34422349 DERIVED

• 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.

  PMID: 30821827 DERIVED

• 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.

  PMID: 28069970 DERIVED

• 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.

  PMID: 27009070 DERIVED

• Marcus PM, Doria-Rose VP, Gareen IF, Brewer B, Clingan K, Keating K, Rosenbaum J, Rozjabek HM, Rathmell J, Sicks J, Miller AB. Did death certificates and a death review process agree on lung cancer cause of death in the National Lung Screening Trial? Clin Trials. 2016 Aug;13(4):434-8. doi: 10.1177/1740774516638345. Epub 2016 Mar 22.

  PMID: 27006427 DERIVED

• 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.

  PMID: 25928649 DERIVED

• 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.

  PMID: 25746779 DERIVED

• Black WC. Computed tomography screening for lung cancer in the National Lung Screening Trial: a cost-effectiveness analysis. J Thorac Imaging. 2015 Mar;30(2):79-87. doi: 10.1097/RTI.0000000000000136.

  PMID: 25635704 DERIVED

• 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.

  PMID: 25372087 DERIVED

• Osinusi A, Kohli A, Marti MM, Nelson A, Zhang X, Meissner EG, Silk R, Townsend K, Pang PS, Subramanian GM, McHutchison JG, Fauci AS, Masur H, Kottilil S. Re-treatment of chronic hepatitis C virus genotype 1 infection after relapse: an open-label pilot study. Ann Intern Med. 2014 Nov 4;161(9):634-8. doi: 10.7326/M14-1211.

  PMID: 25364884 DERIVED

• Pinsky PF, Gierada DS, Hocking W, Patz EF Jr, Kramer BS. National Lung Screening Trial findings by age: Medicare-eligible versus under-65 population. Ann Intern Med. 2014 Nov 4;161(9):627-33. doi: 10.7326/M14-1484.

  PMID: 25199624 DERIVED

• Aberle DR, DeMello S, Berg CD, Black WC, Brewer B, Church TR, Clingan KL, Duan F, Fagerstrom RM, Gareen IF, Gatsonis CA, Gierada DS, Jain A, Jones GC, Mahon I, Marcus PM, Rathmell JM, Sicks J; National Lung Screening Trial Research Team. Results of the two incidence screenings in the National Lung Screening Trial. N Engl J Med. 2013 Sep 5;369(10):920-31. doi: 10.1056/NEJMoa1208962.

  PMID: 24004119 DERIVED

• 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.

  PMID: 23697514 DERIVED

• 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.

  PMID: 22627615 DERIVED

• 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.

  PMID: 19796970 DERIVED

• 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.

  PMID: 17573503 DERIVED

Related Links

• Web site for additional information

MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma; Carcinoma, Non-Small-Cell Lung

Interventions

Tomography, Spiral Computed; Diagnostic Imaging

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Limitations and Caveats

NLST utilized institutions with special expertise. The "healthy volunteer" effect may apply. Scanners are now more technologically advanced. Ongoing LDCT screening may reduce the rate of lung cancer deaths more than three rounds done in NLST.

Results Point of Contact

• Title: Christine D. Berg, M.D.
• Organization: Early Detection Research Group, NCI, NIH

bergc@mail.nih.gov

301-496-8544

Study Officials

• Christine D. Berg, MD

  NCI - Early Detection Research Group

  STUDY DIRECTOR

• Denise R. Aberle, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2002
• First Posted: January 27, 2003
• Study Start: August 1, 2002
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 20, 2014
• Results First Posted: July 6, 2012

Record last verified: 2012-10

Locations

US (33)