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National Lung Screening Trial A Randomized Trial Comparing Low-dose Helical CT With Chest Xray for Lung Cancer

Phase 3
55 Years
74 Years
Not Enrolling
Lung Cancer

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Trial Information

National Lung Screening Trial A Randomized Trial Comparing Low-dose Helical CT With Chest Xray for Lung Cancer


- 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


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

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).

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Lung Cancer Deaths

Outcome Description:

Lung cancer deaths confirmed in participants by Endpoint Verification if available, otherwise by death certificate.

Outcome Time Frame:

All events through December 31, 2009; median follow-up 6.5 years.

Safety Issue:


Principal Investigator

Christine D. Berg, MD

Investigator Role:

Study Director

Investigator Affiliation:

NCI - Early Detection Research Group


United States: Federal Government

Study ID:




Start Date:

August 2002

Completion Date:

October 2010

Related Keywords:

  • Lung Cancer
  • small cell lung cancer
  • non-small cell lung cancer
  • Lung Neoplasms



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Wake Forest University Winston-Salem, North Carolina  27103
University of Iowa Iowa City, Iowa  52242
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Washington University School of Medicine Saint Louis, Missouri  63110
Medical University of South Carolina Charleston, South Carolina  29425-0721
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
University of Utah Health Sciences Center Salt Lake City, Utah  84132
Cancer Institute of New Jersey at Hamilton Hamilton, New Jersey  08690
Emory University School of Medicine Atlanta, Georgia  30322
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756
Mayo Clinic Jacksonville, Florida  32224
Brigham and Women's Hospital Boston, Massachusetts  02115
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania  15213
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Vanderbilt University Nashville, Tennessee  37232-6305
Northwestern University Chicago, Illinois  60611
Henry Ford Health System Detroit, Michigan  48202
Georgetown University Medical Center Washington, District of Columbia  20007
Univeristy of California, San Diego La Jolla, California  92093-0658
University of Colorado Denver Denver, Colorado  80262
Pacific Health Research & Education Institute Honolulu, Hawaii  96813
Jewish Hopsital Heart and Lung Institute Louisville, Kentucky  40202
Ochsner Medical Foundation Hospital New Orleans, Louisiana  70121
University of Minnesota School of Public Health Minneapolis, Minnesota  55455
St Elizabeth Health Center Youngstown, Ohio  44504
University of Pennsylvania Medical Center Philadelphia, Pennsylvania  19104
Brown University, Rhode Island Hospital Providence, Rhode Island  02908-4735
Marshfield Clinic Research Foundation Marshfield, Wisconsin  54449