National Lung Screening Trial (NLST) Screening (NLST)

May 2, 2014 updated by: National Cancer Institute (NCI)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

53454

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • CXR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
All events through December 31, 2009; median follow-up 6.5 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
All events through December 31, 2009; median follow-up 6.5 years.
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.
All events through December 31, 2009; median follow-up 6.5 years
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.
One year from screening examination
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.
T0 (at study entry)
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.
T1 (one year after entry)
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.
T2 (two years after entry)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

October 3, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

May 20, 2014

Last Update Submitted That Met QC Criteria

May 2, 2014

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02002
  • U01CA080098 (U.S. NIH Grant/Contract)
  • U01CA079778 (U.S. NIH Grant/Contract)
  • N1CN25476A-85-0-1 (NIH)
  • NIH/NCI (OTHER: 10 contracts to NCI)
  • CDR0000257938 (REGISTRY: PDQ [Physician Database Query])

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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