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

October 3, 2002
May 2, 2014
August 2002
October 2010   (final data collection date for primary outcome measure)
Lung Cancer Deaths [ Time Frame: All events through December 31, 2009; median follow-up 6.5 years. ] [ Designated as safety issue: No ]
Lung cancer deaths confirmed in participants by Endpoint Verification if available, otherwise by death certificate.
Not Provided
Complete list of historical versions of study NCT00047385 on ClinicalTrials.gov Archive Site
  • Deaths From All Causes in All Randomized Participants. [ Time Frame: All events through December 31, 2009; median follow-up 6.5 years. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Lung cancer diagnoses confirmed by medical record abstraction.
  • Complications of Diagnostic Evaluation Following a Positive Screening Test. [ Time Frame: One year from screening examination ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
Not Provided
 
National Lung Screening Trial (NLST) Screening
National Lung Screening Trial A Randomized Trial Comparing Low-dose Helical CT With Chest Xray for Lung Cancer

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.

OBJECTIVES:

  • 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.

OUTLINE:

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).

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Lung Cancer
  • 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
  • Device: chest radiography
    The chest x-ray in this study was a single posterior-anterior film done with the participant upright.
    Other Name: CXR
  • Experimental: Low-Dose CT
    Intervention: Device: low-dose helical computed tomography
  • Experimental: Chest X-ray
    Intervention: Device: chest radiography

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53454
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 55-74 years (pack-years = packs per day * years smoked)
  • 30 or more pack-years of cigarette smoking history
  • Former smokers: quit smoking within the previous 15 years
  • Ability to lie on the back with arms raised over the head
  • Signed informed consent form

Exclusion Criteria:

  • Metallic implants or devices in the chest or back, such as pacemakers or Harrington fixation rods
  • Treatment for, or evidence of, any cancer other than nonmelanoma skin cancer or carcinoma in situ (with the exception of transitional cell carcinoma in situ or bladder carcinoma in situ) in the 5 years prior to eligibility assessment
  • History of lung cancer
  • History of removal of any portion of the lung, excluding needle biopsy
  • Requirement for home oxygen supplementation
  • Participation in another cancer screening trial
  • Participation in a cancer prevention study, other than a smoking cessation study
  • Unexplained weight loss of more than 15 pounds in the 12 months prior to eligibility assessment
  • Recent hemoptysis
  • Pneumonia or acute respiratory infection treated with antibiotics in the 12 weeks prior to eligibility assessment
  • Chest CT examination in the 18 months prior to eligibility assessment
Both
55 Years to 74 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00047385
NCI-2012-02002, U01CA079778, U01CA080098, N1CN25476A-85-0-1, NIH/NCI, CDR0000257938
Yes
National Cancer Institute (NCI)
National Cancer Institute (NCI)
American College of Radiology Imaging Network
Study Director: Christine D. Berg, MD NCI - Early Detection Research Group
Principal Investigator: Denise R. Aberle, MD Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP