National Lung Screening Trial (NLST) Screening

Phase 3

Completed

Conditions: Lung Cancer

Interventions: Device: low-dose helical computed tomography
Device: chest radiography

Registration Number: NCT00047385

Lead Sponsor: National Cancer Institute (NCI)

Brief Summary: 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.

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 53454

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-Dose CT	low-dose helical computed tomography	-
Chest X-ray	chest radiography	-

Primary Outcome Measures

Name	Time	Method
Lung Cancer Deaths	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.

Secondary Outcome Measures

Name	Time	Method
Deaths From All Causes in All Randomized Participants.	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.
Lung Cancer Diagnoses	All events through December 31, 2009; median follow-up 6.5 years	Lung cancer diagnoses confirmed by medical record abstraction.
Complications of Diagnostic Evaluation Following a Positive Screening Test.	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.
T0 (Baseline) Screening Results	T0 (at study entry)	Results of radiologist's interpretation of images from LDCT or CXR screening exam at T0.
T1 Screening Results	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.
T2 Screening Results	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.

Trial Locations

Locations (33): Johns Hopkins University
🇺🇸
Baltimore, Maryland, United States
St Elizabeth Health Center
🇺🇸
Youngstown, Ohio, United States
Marshfield Clinic Research Foundation
🇺🇸
Marshfield, Wisconsin, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸
Los Angeles, California, United States
Univeristy of California, San Diego
🇺🇸
La Jolla, California, United States
Emory University School of Medicine
🇺🇸
Atlanta, Georgia, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸
Tampa, Florida, United States
University of Michigan Comprehensive Cancer Center
🇺🇸
Ann Arbor, Michigan, United States
Washington University School of Medicine
🇺🇸
St. Louis, Missouri, United States
Mayo Clinic
🇺🇸
Jacksonville, Florida, United States
University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Georgetown University Medical Center
🇺🇸
Washington, District of Columbia, United States
University of Colorado Denver
🇺🇸
Denver, Colorado, United States
Pacific Health Research & Education Institute
🇺🇸
Honolulu, Hawaii, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
University of Iowa
🇺🇸
Iowa City, Iowa, United States
Jewish Hopsital Heart and Lung Institute
🇺🇸
Louisville, Kentucky, United States
Ochsner Medical Foundation Hospital
🇺🇸
New Orleans, Louisiana, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Henry Ford Health System
🇺🇸
Detroit, Michigan, United States
Cancer Institute of New Jersey at Hamilton
🇺🇸
Hamilton, New Jersey, United States
Mayo Clinic Cancer Center
🇺🇸
Rochester, Minnesota, United States
Dartmouth-Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
Wake Forest University
🇺🇸
Winston-Salem, North Carolina, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
University of Pennsylvania Medical Center
🇺🇸
Philadelphia, Pennsylvania, United States
Vanderbilt University
🇺🇸
Nashville, Tennessee, United States
University of Minnesota School of Public Health
🇺🇸
Minneapolis, Minnesota, United States
Brown University, Rhode Island Hospital
🇺🇸
Providence, Rhode Island, United States
University of Utah Health Sciences Center
🇺🇸
Salt Lake City, Utah, United States
University of Texas - MD Anderson Cancer Center
🇺🇸
Houston, Texas, United States