National Lung Screening Trial (NLST) Screening

This study has been completed.
Sponsor:
Collaborator:
American College of Radiology Imaging Network
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00047385
First received: October 3, 2002
Last updated: May 2, 2014
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
  Description
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  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     19612     19622     39234  
>=65 years     7110     7110     14220  
Age  
[units: years]
Mean ± Standard Deviation
  61.4  ± 5.0     61.4  ± 5.0     61.4  ± 5.0  
Gender  
[units: participants]
     
Female     10952     10970     21922  
Male     15770     15762     31532  
Region of Enrollment  
[units: participants]
     
United States     26,722     26,732     53454  



  Outcome Measures
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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


  Limitations and Caveats
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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.


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