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: bronchoscopic and lung imaging studies Procedure: comparison of screening methods

Study Type:	Interventional
Study Design:	Screening, Randomized, Active Control
Official Title:	National Lung Screening Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer X-Rays

U.S. FDA Resources

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

Study Start Date:

September 2002

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:

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.

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 National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	CDR0000257938, NCI-NLST, ACRIN-NCI-NLST
Study First Received:	October 3, 2002
Last Updated:	November 25, 2009
ClinicalTrials.gov Identifier:	NCT00047385 History of Changes
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:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on November 27, 2009