Clinical trial NCT00047385: National Lung Screening Trial (NLST) Screening
Official title: National Lung Screening Trial A Randomized Trial Comparing Low-dose Helical CT With Chest Xray for Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Keywords: small cell lung cancer
non-small cell lung cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: American College of Radiology Imaging Network
First posted: 2003-01-27
Enrollment: 53454
Sex: ALL
Minimum age (years): 55
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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).

Eligibility 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

Primary outcomes:
measure: Lung Cancer Deaths
timeFrame: All events through December 31, 2009; median follow-up 6.5 years.
Secondary outcomes:
measure: Deaths From All Causes in All Randomized Participants.
timeFrame: All events through December 31, 2009; median follow-up 6.5 years.
measure: Lung Cancer Diagnoses
timeFrame: All events through December 31, 2009; median follow-up 6.5 years
measure: Complications of Diagnostic Evaluation Following a Positive Screening Test.
timeFrame: One year from screening examination
measure: T0 (Baseline) Screening Results
timeFrame: T0 (at study entry)
measure: T1 Screening Results
timeFrame: T1 (one year after entry)
measure: T2 Screening Results
timeFrame: T2 (two years after entry)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: La Jolla
country: United States
facility: Univeristy of California, San Diego
state: California
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
city: Denver
country: United States
facility: University of Colorado Denver
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Honolulu
country: United States
facility: Pacific Health Research & Education Institute
state: Hawaii
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Louisville
country: United States
facility: Jewish Hopsital Heart and Lung Institute
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Foundation Hospital
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota School of Public Health
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Hamilton
country: United States
facility: Cancer Institute of New Jersey at Hamilton
state: New Jersey
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Youngstown
country: United States
facility: St Elizabeth Health Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Brown University, Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
city: Marshfield
country: United States
facility: Marshfield Clinic Research Foundation
state: Wisconsin
Study officials:
affiliation: NCI - Early Detection Research Group
name: Christine D. Berg, MD
role: STUDY_DIRECTOR
affiliation: Jonsson Comprehensive Cancer Center
name: Denise R. Aberle, MD
role: PRINCIPAL_INVESTIGATOR
References:
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