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
RATIONALE: Effective screening tests should help doctors detect lung cancer early and plan curative treatment. It is not yet known whether low-dose helical computed tomography (LDCT) screening is more effective than chest radiography (CXR) screening in reducing death from lung cancer.
PURPOSE: Randomized clinical trial to compare the effectiveness of LDCT scan with that of CXR in screening individuals who are at high risk for developing lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Device: low-dose helical computed tomography Device: chest radiography||Phase 3|
- Compare whether screening with low-dose helical CT scan vs chest x-ray reduces lung cancer-specific mortality in participants who are at high risk for developing lung cancer.
NLST participants were randomized to either low-dose helical CT or chest x-ray in equal proportions. A total of 53,454 participants were enrolled (26,722 in low-dose CT and 26,732 in chest radiography) at 33 screening centers across the United States. Screening was offered three times (at baseline and two annual follow-up examinations). The primary endpoint of the study was lung cancer mortality. The study arms were compared with regard to overall mortality, lung cancer incidence, and screening-related complications.
All low-dose scanners and chest x-ray machines were certified for use and met NLST protocol requirements and American College of Radiology guidelines. Low-dose CT acquisitions and chest radiographs were interpreted by trained radiologists. Participants and their health care provider were informed of study examination results. Participants with abnormalities suspicious for lung cancer were contacted for information regarding diagnostic evaluation. Medical records were collected on diagnostic evaluation, medical complications, and initial treatment.
Participants were then contacted at least annually by mail or telephone.
The National Lung Screening Trial (NLST) represents the union of two NCI-sponsored efforts, the NCI Lung Screening Study and the American College of Radiology Imaging Network (ACRIN).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53454 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||National Lung Screening Trial A Randomized Trial Comparing Low-dose Helical CT With Chest Xray for Lung Cancer|
|Study Start Date :||August 2002|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
|Experimental: Low-Dose CT||
Device: low-dose helical computed tomography
A LDCT is a computerized tomography image with low-dose technique without contrast. The scan is done from the neck to the diaphragm in one breath-hold.
Other Name: LDCT
|Experimental: Chest X-ray||
Device: chest radiography
The chest x-ray in this study was a single posterior-anterior film done with the participant upright.
Other Name: CXR
- Lung Cancer Deaths [ Time Frame: All events through December 31, 2009; median follow-up 6.5 years. ]Lung cancer deaths confirmed in participants by Endpoint Verification if available, otherwise by death certificate.
- Deaths From All Causes in All Randomized Participants. [ Time Frame: All events through December 31, 2009; median follow-up 6.5 years. ]Deaths from all causes were compared between the low-dose CT group and the chest radiography group among all randomized participants.
- Lung Cancer Diagnoses [ Time Frame: All events through December 31, 2009; median follow-up 6.5 years ]Lung cancer diagnoses confirmed by medical record abstraction.
- Complications of Diagnostic Evaluation Following a Positive Screening Test. [ Time Frame: One year from screening examination ]Number of participants who experienced complications during diagnostic work-up of a screening CT or CXR that was suspicious for lung cancer.
- T0 (Baseline) Screening Results [ Time Frame: T0 (at study entry) ]Results of radiologist's interpretation of images from LDCT or CXR screening exam at T0.
- T1 Screening Results [ Time Frame: T1 (one year after entry) ]Results of radiologist's interpretation of images from LDCT or CXR screening exam at T1. Includes a comparison with images from T0 screen.
- T2 Screening Results [ Time Frame: T2 (two years after entry) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00047385
|Study Director:||Christine D. Berg, MD||NCI - Early Detection Research Group|
|Principal Investigator:||Denise R. Aberle, MD||Jonsson Comprehensive Cancer Center|