National Lung Screening Trial (NLST) Screening

This study has been completed.
American College of Radiology Imaging Network
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: October 3, 2002
Last updated: October 16, 2012
Last verified: October 2012
Results First Received: May 30, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Screening
Condition: Lung Cancer
Interventions: Device: low-dose helical computed tomography
Device: chest radiography

  Participant Flow

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Low-Dose CT Participants undergo low-dose helical CT examination.
Chest X-ray Participants undergo chest x-ray examination.
Total Total of all reporting groups

Baseline Measures
    Low-Dose CT     Chest X-ray     Total  
Number of Participants  
[units: participants]
  26722     26732     53454  
[units: participants]
<=18 years     0     0     0  
Between 18 and 65 years     19612     19622     39234  
>=65 years     7110     7110     14220  
[units: years]
Mean ± Standard Deviation
  61.4  ± 5.0     61.4  ± 5.0     61.4  ± 5.0  
[units: participants]
Female     10952     10970     21922  
Male     15770     15762     31532  
Region of Enrollment  
[units: participants]
United States     26,722     26,732     53454  

  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Lung Cancer Deaths   [ Time Frame: All events through December 31, 2009; median follow-up 6.5 years. ]

2.  Secondary:   Deaths From All Causes in All Randomized Participants.   [ Time Frame: All events through December 31, 2009; median follow-up 6.5 years. ]

3.  Secondary:   Lung Cancer Diagnoses   [ Time Frame: All events through December 31, 2009; median follow-up 6.5 years ]

4.  Secondary:   Complications of Diagnostic Evaluation Following a Positive Screening Test.   [ Time Frame: One year from screening examination ]

5.  Secondary:   T0 (Baseline) Screening Results   [ Time Frame: T0 (at study entry) ]

6.  Secondary:   T1 Screening Results   [ Time Frame: T1 (one year after entry) ]

7.  Secondary:   T2 Screening Results   [ Time Frame: T2 (two years after entry) ]

  Serious Adverse Events

  Other Adverse Events

  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:  
Name/Title: Christine D. Berg, M.D.
Organization: Early Detection Research Group, NCI, NIH
phone: 301-496-8544

Publications of Results:
Other Publications:
Publications automatically indexed to this study:

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00047385     History of Changes
Obsolete Identifiers: NCT00028808
Other Study ID Numbers: CDR0000257938, U01CA079778, U01CA080098, N1CN25476A-85-0-1, NIH/NCI
Study First Received: October 3, 2002
Results First Received: May 30, 2012
Last Updated: October 16, 2012
Health Authority: United States: Federal Government