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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: October 16, 2012
Last verified: October 2012
History of Changes
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was from August 2002 through April 2004 at 33 NLST sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants signed a study informed consent prior to being randomized to a study arm.

Reporting Groups
  Description
Low-Dose CT Participants undergo low-dose helical CT examination.
Chest X-ray Participants undergo chest x-ray examination.

Participant Flow:   Overall Study
    Low-Dose CT     Chest X-ray  
STARTED     26722     26732  
COMPLETED     26455 [1]   26232  
NOT COMPLETED     267     500  
Death before any screening                 2                 5  
Lung Cancer diagnosed before screening                 5                 3  
Eligible for screening but had no screen                 260                 492  
[1] Had at least one screening exam.



  Baseline Characteristics
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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. ]
  Show Outcome Measure 1

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

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

Measure Type Secondary
Measure Title Lung Cancer Diagnoses
Measure Description Lung cancer diagnoses confirmed by medical record abstraction.
Time Frame All events through December 31, 2009; median follow-up 6.5 years  
Safety Issue No  

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.
All participants randomized were analyzed. An intention-to-treat analysis was performed.

Reporting Groups
  Description
LDCT Screening Participants randomized to receive three annual low-dose helical CT exams of the chest.
CXR Screening Participants randomized to receive three annual chest radiographs.

Measured Values
    LDCT Screening     CXR Screening  
Number of Participants Analyzed  
[units: participants]
 		  26722     26732  
Lung Cancer Diagnoses  
[units: Participants]
 		  1060     941  


Statistical Analysis 1 for Lung Cancer Diagnoses
Groups [1] All groups
Hazard Ratio (HR) [2] 1.13
95% Confidence Interval ( 1.03 to 1.23 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  Denominator: LDCT Group Numerator: CXR Group



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

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

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

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


  Serious Adverse Events
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  Other Adverse Events
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  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
e-mail: bergc@mail.nih.gov


Publications of Results:

Other Publications:

Publications automatically indexed to this study:


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov 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