National Lung Screening Trial (NLST) Screening

Lung Cancer Clinical Trial

— NLST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00047385
• Other study ID #: NCI-2012-02002
• Secondary ID: U01CA079778U01CA
• Status: Completed
• Phase: Phase 3
• First received: October 3, 2002
• Last updated: May 2, 2014
• Start date: August 2002
• Est. completion date: October 2010

Study information

• Verified date: October 2012
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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).

Other known NCT identifiers

• NCT00028808

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53454
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 74 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Device:
• low-dose helical computed tomography
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.
• chest radiography
The chest x-ray in this study was a single posterior-anterior film done with the participant upright.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)	American College of Radiology Imaging Network

Country where clinical trial is conducted

United States, 

References & Publications (9)

Clark KW, Gierada DS, Marquez G, Moore SM, Maffitt DR, Moulton JD, Wolfsberger MA, Koppel P, Phillips SR, Prior FW. Collecting 48,000 CT exams for the lung screening study of the National Lung Screening Trial. J Digit Imaging. 2009 Dec;22(6):667-80. doi: 10.1007/s10278-008-9145-9. Epub 2008 Sep 6. — View Citation

Cody DD, Kim HJ, Cagnon CH, Larke FJ, McNitt-Gray MM, Kruger RL, Flynn MJ, Seibert JA, Judy PF, Wu X. Normalized CT dose index of the CT scanners used in the National Lung Screening Trial. AJR Am J Roentgenol. 2010 Jun;194(6):1539-46. doi: 10.2214/AJR.09.3268. — View 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. — View Citation

Gierada DS, Pilgram TK, Ford M, Fagerstrom RM, Church TR, Nath H, Garg K, Strollo DC. Lung cancer: interobserver agreement on interpretation of pulmonary findings at low-dose CT screening. Radiology. 2008 Jan;246(1):265-72. Epub 2007 Nov 16. — View 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; — View Citation

National Lung Screening Trial Research Team, Aberle DR, Adams AM, Berg CD, Clapp JD, Clingan KL, Gareen IF, Lynch DA, Marcus PM, Pinsky PF. Baseline characteristics of participants in the randomized national lung screening trial. J Natl Cancer Inst. 2010 — View Citation

National Lung Screening Trial Research Team, Aberle DR, Berg CD, Black WC, Church TR, Fagerstrom RM, Galen B, Gareen IF, Gatsonis C, Goldin J, Gohagan JK, Hillman B, Jaffe C, Kramer BS, Lynch D, Marcus PM, Schnall M, Sullivan DC, Sullivan D, Zylak CJ. The National Lung Screening Trial: overview and study design. Radiology. 2011 Jan;258(1):243-53. doi: 10.1148/radiol.10091808. Epub 2010 Nov 2. — View Citation

Park ER, Ostroff JS, Rakowski W, Gareen IF, Diefenbach MA, Feibelmann S, Rigotti NA. Risk perceptions among participants undergoing lung cancer screening: baseline results from the National Lung Screening Trial. Ann Behav Med. 2009 Jun;37(3):268-79. doi: — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Cancer Deaths	Lung cancer deaths confirmed in participants by Endpoint Verification if available, otherwise by death certificate.	All events through December 31, 2009; median follow-up 6.5 years.	No
Secondary	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.	All events through December 31, 2009; median follow-up 6.5 years.	No
Secondary	Lung Cancer Diagnoses	Lung cancer diagnoses confirmed by medical record abstraction.	All events through December 31, 2009; median follow-up 6.5 years	No
Secondary	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.	One year from screening examination	Yes
Secondary	T0 (Baseline) Screening Results	Results of radiologist's interpretation of images from LDCT or CXR screening exam at T0.	T0 (at study entry)	No
Secondary	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.	T1 (one year after entry)	No
Secondary	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.	T2 (two years after entry)	No

External Links

•   Web site for additional information