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
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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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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.
No text entered.

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
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Time Frame During each annual screening visit.
Additional Description These events are solely those prompted by the screening examination.

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

Serious Adverse Events
    Low-Dose CT     Chest X-ray  
Total, serious adverse events      
# participants affected / at risk     0/26722 (0.00%)     2/26732 (0.01%)  
Cardiac disorders      
Cardiac symptoms * [2]    
# participants affected / at risk     0/26722 (0.00%)     1/26732 (0.00%)  
# events     0     1  
General disorders      
Nausea/vomiting, bradycardia, diaphoresis * [3]    
# participants affected / at risk     0/26722 (0.00%)     1/26732 (0.00%)  
# events     0     1  
* Events were collected by non-systematic assessment
[2] Shortness of breath, diaphoresis, jaw pain and general cardiac symptoms. Admitted to hospital; MI ruled out. Treated with medication/inhalers for COPD exacerbation. Stable through the admission; fully recovered the following day.
[3] Transient syncope w/ vomiting/bradycardia/diaphoresis/ashen color after phlebotomy and single forced expiration for spirometry. Hospitalized for monitoring; MI ruled out. Recovered with time, rest, and liquids.




  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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