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Trial record 1 of 1 for:    18024436 [PUBMED-IDS]
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National Lung Screening Trial (NLST) Screening (NLST)

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ClinicalTrials.gov Identifier: NCT00047385
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : July 6, 2012
Last Update Posted : May 20, 2014
Sponsor:
Collaborator:
American College of Radiology Imaging Network
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition Lung Cancer
Interventions Device: low-dose helical computed tomography
Device: chest radiography
Enrollment 53454
Recruitment Details Recruitment was from August 2002 through April 2004 at 33 NLST sites.
Pre-assignment Details Participants signed a study informed consent prior to being randomized to a study arm.
Arm/Group Title Low-Dose CT Chest X-ray
Hide Arm/Group Description Participants undergo low-dose helical CT examination. Participants undergo chest x-ray examination.
Period Title: Overall Study
Started 26722 26732
Completed 26455 [1] 26232
Not Completed 267 500
Reason Not Completed
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.
Arm/Group Title Low-Dose CT Chest X-ray Total
Hide Arm/Group Description Participants undergo low-dose helical CT examination. Participants undergo chest x-ray examination. Total of all reporting groups
Overall Number of Baseline Participants 26722 26732 53454
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26722 participants 26732 participants 53454 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19612
  73.4%
19622
  73.4%
39234
  73.4%
>=65 years
7110
  26.6%
7110
  26.6%
14220
  26.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26722 participants 26732 participants 53454 participants
61.4  (5.0) 61.4  (5.0) 61.4  (5.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26722 participants 26732 participants 53454 participants
Female
10952
  41.0%
10970
  41.0%
21922
  41.0%
Male
15770
  59.0%
15762
  59.0%
31532
  59.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26722 participants 26732 participants 53454 participants
26,722 26,732 53454
1.Primary Outcome
Title Lung Cancer Deaths
Hide Description Lung cancer deaths confirmed in participants by Endpoint Verification if available, otherwise by death certificate.
Time Frame All events through December 31, 2009; median follow-up 6.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomized were analyzed. An intention-to-treat analysis was performed.
Arm/Group Title LDCT Screening CXR Screening
Hide Arm/Group Description:
Participants randomized to receive three annual low-dose helical CT exams of the chest.
Participants randomized to receive three annual chest radiographs.
Overall Number of Participants Analyzed 26722 26732
Measure Type: Number
Unit of Measure: Participants
356 443
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LDCT Screening, CXR Screening
Comments

Alternative hypothesis: LDCT screening reduces lung cancer mortality relative to chest x-ray.

Power: 90% for a 20% reduction in lung cancer mortality.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments P-value is adjusted for multiple comparisons.
Method Weighted log-rank (details below)
Comments Weights in weighted log-rank statistic increased linearly from zero at randomization to full weight at 4 years and thereafter.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.800
Confidence Interval (2-Sided) 95%
0.733 to 0.932
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Deaths From All Causes in All Randomized Participants.
Hide Description Deaths from all causes were compared between the low-dose CT group and the chest radiography group among all randomized participants.
Time Frame All events through December 31, 2009; median follow-up 6.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomized were analyzed. An intention-to-treat analysis was performed.
Arm/Group Title LDCT Screening CXR Screening
Hide Arm/Group Description:
Participants randomized to receive three annual low-dose helical CT exams of the chest.
Participants randomized to receive three annual chest radiographs.
Overall Number of Participants Analyzed 26722 26732
Measure Type: Number
Unit of Measure: Participants
1877 2000
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LDCT Screening, CXR Screening
Comments Alternative hypothesis: LDCT screening reduced all-cause mortality relative to chest x-ray.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments No adjustment for multiple comparisons. Only one analysis performed.
Method Weighted log-rank (details below)
Comments Weights in weighted log-rank statistic increased linearly from zero at randomization to full weight at 4 years and thereafter.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.933
Confidence Interval (2-Sided) 95%
0.864 to 0.988
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Lung Cancer Diagnoses
Hide Description Lung cancer diagnoses confirmed by medical record abstraction.
Time Frame All events through December 31, 2009; median follow-up 6.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomized were analyzed. An intention-to-treat analysis was performed.
Arm/Group Title LDCT Screening CXR Screening
Hide Arm/Group Description:
Participants randomized to receive three annual low-dose helical CT exams of the chest.
Participants randomized to receive three annual chest radiographs.
Overall Number of Participants Analyzed 26722 26732
Measure Type: Number
Unit of Measure: Participants
1060 941
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LDCT Screening, CXR Screening
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
1.03 to 1.23
Estimation Comments Denominator: LDCT Group Numerator: CXR Group
4.Secondary Outcome
Title Complications of Diagnostic Evaluation Following a Positive Screening Test.
Hide Description Number of participants who experienced complications during diagnostic work-up of a screening CT or CXR that was suspicious for lung cancer.
Time Frame One year from screening examination
Hide Outcome Measure Data
Hide Analysis Population Description
The units analyzed were positive screening exams with documented diagnostic follow-up. If participant received 3 positive screens with documented follow-up after each one, he/she would be counted 3 times in the number of units analyzed.
Arm/Group Title LDCT Screening CXR Screening
Hide Arm/Group Description:
Participants randomized to receive three annual low-dose helical CT exams of the chest.
Participants randomized to receive three annual chest radiographs.
Overall Number of Participants Analyzed 26722 26732
Overall Number of Units Analyzed
Type of Units Analyzed: Positive Screens with Follow-up
17702 4953
Measure Type: Number
Unit of Measure: Pos. screens w/ complications
245 81
5.Secondary Outcome
Title T0 (Baseline) Screening Results
Hide Description Results of radiologist's interpretation of images from LDCT or CXR screening exam at T0.
Time Frame T0 (at study entry)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomized were analyzed.
Arm/Group Title LDCT Screening CXR Screening
Hide Arm/Group Description:
Participants randomized to receive three annual low-dose helical CT exams of the chest.
Participants randomized to receive three annual chest radiographs.
Overall Number of Participants Analyzed 26722 26732
Measure Type: Number
Unit of Measure: Participants
Positive 7191 2387
Significant abnor. not suspicious for lung cancer 2695 785
No, or minor abnormality 16423 22863
Eligible but not screened 406 689
Not eligible for screen 7 8
6.Secondary Outcome
Title T1 Screening Results
Hide Description Results of radiologist's interpretation of images from LDCT or CXR screening exam at T1. Includes a comparison with images from T0 screen.
Time Frame T1 (one year after entry)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomized were analyzed
Arm/Group Title LDCT Screening CXR Screening
Hide Arm/Group Description:
Participants randomized to receive three annual low-dose helical CT exams of the chest.
Participants randomized to receive three annual chest radiographs.
Overall Number of Participants Analyzed 26722 26732
Measure Type: Number
Unit of Measure: Participants
Positive 6901 1482
Significant abnor. not suspicious for lung cancer 1519 429
No, or minor abnormality 16295 22178
Eligible but not screened 1570 2321
Not eligible for screen 437 322
7.Secondary Outcome
Title T2 Screening Results
Hide Description Results of radiologist's interpretation of images from LDCT or CXR screening exam at T2. Includes a comparison with images from T0 and T1 screens.
Time Frame T2 (two years after entry)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomized were analyzed
Arm/Group Title LDCT Screening CXR Screening
Hide Arm/Group Description:
Participants randomized to receive three annual low-dose helical CT exams of the chest.
Participants randomized to receive three annual chest radiographs.
Overall Number of Participants Analyzed 26722 26732
Measure Type: Number
Unit of Measure: Participants
Positive 4054 1174
Significant abnor. not suspicious for lung cancer 1408 361
No, or minor abnormality 18640 21811
Eligible but not screened 1840 2764
Not eligible for screen 780 622
Time Frame During each annual screening visit.
Adverse Event Reporting Description These events are solely those prompted by the screening examination.
 
Arm/Group Title Low-Dose CT Chest X-ray
Hide Arm/Group Description Participants undergo low-dose helical CT examination. Participants undergo chest x-ray examination.
All-Cause Mortality
Low-Dose CT Chest X-ray
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Low-Dose CT Chest X-ray
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26722 (0.00%)      2/26732 (0.01%)    
Cardiac disorders     
Cardiac symptoms * [1]  0/26722 (0.00%)  0 1/26732 (0.00%)  1
General disorders     
Nausea/vomiting, bradycardia, diaphoresis * [2]  0/26722 (0.00%)  0 1/26732 (0.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
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.
[2]
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.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Low-Dose CT Chest X-ray
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26722 (0.00%)      0/26732 (0.00%)    
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00047385     History of Changes
Obsolete Identifiers: NCT00028808
Other Study ID Numbers: NCI-2012-02002
U01CA079778 ( U.S. NIH Grant/Contract )
U01CA080098 ( U.S. NIH Grant/Contract )
N1CN25476A-85-0-1 ( U.S. NIH Grant/Contract )
NIH/NCI ( Other Identifier: 10 contracts to NCI )
CDR0000257938 ( Registry Identifier: PDQ [Physician Database Query] )
First Submitted: October 3, 2002
First Posted: January 27, 2003
Results First Submitted: May 30, 2012
Results First Posted: July 6, 2012
Last Update Posted: May 20, 2014