Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

National Lung Screening Trial (NLST) Screening (NLST)

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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  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


  Limitations and Caveats


  More Information