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National Lung Screening Trial (NLST) Screening (NLST)

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
low-dose helical computed tomography
chest radiography
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Cancer focused on measuring small cell lung cancer, non-small cell lung cancer

Eligibility Criteria

55 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Univeristy of California, San Diego
  • Jonsson Comprehensive Cancer Center, UCLA
  • University of Colorado Denver
  • Georgetown University Medical Center
  • Mayo Clinic
  • H. Lee Moffitt Cancer Center and Research Institute
  • Emory University School of Medicine
  • Pacific Health Research & Education Institute
  • Northwestern University
  • University of Iowa
  • Jewish Hopsital Heart and Lung Institute
  • Ochsner Medical Foundation Hospital
  • Johns Hopkins University
  • Brigham and Women's Hospital
  • Beth Israel Deaconess Medical Center
  • University of Michigan Comprehensive Cancer Center
  • Henry Ford Health System
  • University of Minnesota School of Public Health
  • Mayo Clinic Cancer Center
  • Washington University School of Medicine
  • Dartmouth-Hitchcock Medical Center
  • Cancer Institute of New Jersey at Hamilton
  • Wake Forest University
  • St Elizabeth Health Center
  • University of Pennsylvania Medical Center
  • University of Pittsburgh Medical Center
  • Brown University, Rhode Island Hospital
  • Medical University of South Carolina
  • Vanderbilt University
  • University of Texas - MD Anderson Cancer Center
  • University of Utah Health Sciences Center
  • Marshfield Clinic Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low-Dose CT

Chest X-ray

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Deaths From All Causes in All Randomized Participants.
Deaths from all causes were compared between the low-dose CT group and the chest radiography group among all randomized participants.
Lung Cancer Diagnoses
Lung cancer diagnoses confirmed by medical record abstraction.
Complications of Diagnostic Evaluation Following a Positive Screening Test.
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
Results of radiologist's interpretation of images from LDCT or CXR screening exam at T0.
T1 Screening Results
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
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.

Full Information

First Posted
October 3, 2002
Last Updated
May 2, 2014
Sponsor
National Cancer Institute (NCI)
Collaborators
American College of Radiology Imaging Network
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1. Study Identification

Unique Protocol Identification Number
NCT00047385
Brief Title
National Lung Screening Trial (NLST) Screening
Acronym
NLST
Official Title
National Lung Screening Trial A Randomized Trial Comparing Low-dose Helical CT With Chest Xray for Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
Collaborators
American College of Radiology Imaging Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
small cell lung cancer, non-small cell lung cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53454 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-Dose CT
Arm Type
Experimental
Arm Title
Chest X-ray
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
low-dose helical computed tomography
Other Intervention Name(s)
LDCT
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
chest radiography
Other Intervention Name(s)
CXR
Intervention Description
The chest x-ray in this study was a single posterior-anterior film done with the participant upright.
Primary Outcome Measure Information:
Title
Lung Cancer Deaths
Description
Lung cancer deaths confirmed in participants by Endpoint Verification if available, otherwise by death certificate.
Time Frame
All events through December 31, 2009; median follow-up 6.5 years.
Secondary Outcome Measure Information:
Title
Deaths From All Causes in All Randomized Participants.
Description
Deaths from all causes were compared between the low-dose CT group and the chest radiography group among all randomized participants.
Time Frame
All events through December 31, 2009; median follow-up 6.5 years.
Title
Lung Cancer Diagnoses
Description
Lung cancer diagnoses confirmed by medical record abstraction.
Time Frame
All events through December 31, 2009; median follow-up 6.5 years
Title
Complications of Diagnostic Evaluation Following a Positive Screening Test.
Description
Number of participants who experienced complications during diagnostic work-up of a screening CT or CXR that was suspicious for lung cancer.
Time Frame
One year from screening examination
Title
T0 (Baseline) Screening Results
Description
Results of radiologist's interpretation of images from LDCT or CXR screening exam at T0.
Time Frame
T0 (at study entry)
Title
T1 Screening Results
Description
Results of radiologist's interpretation of images from LDCT or CXR screening exam at T1. Includes a comparison with images from T0 screen.
Time Frame
T1 (one year after entry)
Title
T2 Screening Results
Description
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.
Time Frame
T2 (two years after entry)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine D. Berg, MD
Organizational Affiliation
NCI - Early Detection Research Group
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Denise R. Aberle, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Univeristy of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
University of Colorado Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Pacific Health Research & Education Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1011
Country
United States
Facility Name
Jewish Hopsital Heart and Lung Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Ochsner Medical Foundation Hospital
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0942
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University of Minnesota School of Public Health
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Cancer Institute of New Jersey at Hamilton
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27106
Country
United States
Facility Name
St Elizabeth Health Center
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44504
Country
United States
Facility Name
University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Brown University, Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908-4735
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Marshfield Clinic Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21045183
Citation
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Citation
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Results Reference
background
PubMed Identifier
18777192
Citation
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Results Reference
background
PubMed Identifier
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Citation
Gierada DS, Garg K, Nath H, Strollo DC, Fagerstrom RM, Ford MB. CT quality assurance in the lung screening study component of the National Lung Screening Trial: implications for multicenter imaging trials. AJR Am J Roentgenol. 2009 Aug;193(2):419-24. doi: 10.2214/AJR.08.1995.
Results Reference
background
PubMed Identifier
21714641
Citation
National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
Results Reference
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PubMed Identifier
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Citation
Singh S, Pinsky P, Fineberg NS, Gierada DS, Garg K, Sun Y, Nath PH. Evaluation of reader variability in the interpretation of follow-up CT scans at lung cancer screening. Radiology. 2011 Apr;259(1):263-70. doi: 10.1148/radiol.10101254. Epub 2011 Jan 19.
Results Reference
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
28069970
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PubMed Identifier
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PubMed Identifier
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Links:
URL
http://www.cancer.gov/nlst
Description
Web site for additional information

Learn more about this trial

National Lung Screening Trial (NLST) Screening

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