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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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