National Lung Screening Trial (NLST) - Full Text View

Sponsor:	National Cancer Institute (NCI)
Collaborator:	American College of Radiology Imaging Network
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00047385

Purpose

RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for lung cancer. It is not yet known whether helical CT scan is more effective than chest x-ray in reducing death from lung cancer.

PURPOSE: Randomized clinical trial to compare the effectiveness of helical CT scan with that of chest x-ray in screening individuals who are at high risk for developing lung cancer.

Condition	Intervention
Lung Cancer	Procedure: computed tomography Procedure: radiography

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Screening
Official Title:	National Lung Screening Trial

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Lung Cancer Nuclear Scans X-Rays

Drug Information available for: X-Rays

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	53454
Study Start Date:	September 2002
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I Participants undergo helical CT scan.	Procedure: computed tomography Undergo helial CT scan
Experimental: Arm II Participants undergo chest x-ray.	Procedure: radiography Undergo chest x-ray

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: This is a randomized, multicenter study. Participants are randomized to 1 of 2 screening arms.

Arm I: Participants undergo helical CT scan.
Arm II: Participants undergo chest x-ray. Participants in both arms undergo screening initially and then annually for 2 years.

Participants will then be contacted annually by mail or telephone for several years.

The National Lung Screening Trial (NLST) represents the union of two NCI-sponsored activities, the NCI Lung Screening Study I and the American College of Radiology Imaging Network (ACRIN). For more information, please access the ACRIN trial on Cancer.gov. The protocol ID is ACRIN-6654.

PROJECTED ACCRUAL: A total of 50,000 participants will be accrued for this study within 2 years.

Eligibility

Ages Eligible for Study:	55 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Heavy smoker or former smoker (quit within last 15 years)
No prior cancer (other than nonmelanoma skin cancer or in situ cancer) within past 5 years

PATIENT CHARACTERISTICS:

Age

55 to 74

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047385

Show 37 Study Locations

Sponsors and Collaborators

National Cancer Institute (NCI)

American College of Radiology Imaging Network

Investigators

Study Chair:	Christine D. Berg, MD	NCI - Early Detection Research Group
Principal Investigator:	Denise R. Aberle, MD	Jonsson Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Web site for additional information This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2011 Jun 29.

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. Epub 2011 Jan 19.

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 Dec 1;102(23):1771-9. Epub 2010 Nov 22.

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. Epub 2009 Aug 27.

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.

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. Epub 2010 Nov 2.

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.

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. Epub 2008 Sep 6.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Matsuoka S, Washko GR, Dransfield MT, Yamashiro T, San Jose Estepar R, Diaz A, Silverman EK, Patz S, Hatabu H. Quantitative CT measurement of cross-sectional area of small pulmonary vessel in COPD: correlations with emphysema and airflow limitation. Acad Radiol. 2010 Jan;17(1):93-9. Epub 2009 Sep 30.

Dransfield MT, Washko GR, Foreman MG, Estepar RS, Reilly J, Bailey WC. Gender differences in the severity of CT emphysema in COPD. Chest. 2007 Aug;132(2):464-70. Epub 2007 Jun 15.

Responsible Party:	Christine D. Berg, NCI - Early Detection Research Group
ClinicalTrials.gov Identifier:	NCT00047385 History of Changes
Obsolete Identifiers:	NCT00028808
Other Study ID Numbers:	CDR0000257938, NCI-NLST, ACRIN-NCI-NLST
Study First Received:	October 3, 2002
Last Updated:	August 19, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

small cell lung cancer
non-small cell lung cancer

Additional relevant MeSH terms:

Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site

Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 12, 2012