Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Related Information
Registry Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Screening Closed 55 to 74 NCI NCI-NLST ACRIN-NCI-NLST, NCT00047385

Objectives

1. 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.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Patient Characteristics:

Age

• 55 to 74

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Expected Enrollment

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

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.

Gierada DS, Pilgram TK, Ford M, et al.: Lung cancer: interobserver agreement on interpretation of pulmonary findings at low-dose CT screening. Radiology 246 (1): 265-72, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

National Cancer Institute

Christine Berg, MD, Protocol chair		Ph: 301-496-8544 Email: bergc@mail.nih.gov

American College of Radiology Imaging Network

Denise Aberle, MD, Principal investigator		Ph: 310-794-8989; 888-798-0719

Related Information

Web site for additional information

Registry Information
Official Title		National Lung Screening Trial
Trial Start Date		2002-09-24
Registered in ClinicalTrials.gov		NCT00047385
Date Submitted to PDQ		2002-09-13
Information Last Verified		2004-04-05