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
  Purpose

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 Intervention Phase
Lung Cancer
Device: low-dose helical computed tomography
Device: chest radiography
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: National Lung Screening Trial A Randomized Trial Comparing Low-dose Helical CT With Chest Xray for Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 53454
Study Start Date: August 2002
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   55 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047385

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, California
Univeristy of California, San Diego
La Jolla, California, United States, 92093-0658
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
United States, Colorado
University of Colorado Denver
Denver, Colorado, United States, 80262
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Hawaii
Pacific Health Research & Education Institute
Honolulu, Hawaii, United States, 96813
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242-1011
United States, Kentucky
Jewish Hopsital Heart and Lung Institute
Louisville, Kentucky, United States, 40202
United States, Louisiana
Ochsner Medical Foundation Hospital
New Orleans, Louisiana, United States, 70121
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
University of Minnesota School of Public Health
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63108
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27106
United States, Ohio
St Elizabeth Health Center
Youngstown, Ohio, United States, 44504
United States, Pennsylvania
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15236
United States, Rhode Island
Brown University, Rhode Island Hospital
Providence, Rhode Island, United States, 02908-4735
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232-6838
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84112
United States, Wisconsin
Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
American College of Radiology Imaging Network
Investigators
Study Director: Christine D. Berg, MD NCI - Early Detection Research Group
Principal Investigator: Denise R. Aberle, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
Publications:

Additional 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, U01CA080098, N1CN25476A-85-0-1, NIH/NCI, CDR0000257938
Study First Received: October 3, 2002
Results First Received: May 30, 2012
Last Updated: May 2, 2014
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
small cell lung cancer
non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014