Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Related Information
Registry Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Screening | Closed | 55 to 74 | NCI | NCI-NLST ACRIN-NCI-NLST, NCT00047385 |
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.
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
53454A 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.
Published ResultsLarke FJ, Kruger RL, Cagnon CH, et al.: Estimated radiation dose associated with low-dose chest CT of average-size participants in the National Lung Screening Trial. AJR Am J Roentgenol 197 (5): 1165-9, 2011.[PUBMED Abstract]
Aberle DR, Adams AM, Berg CD, et al.: Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med 365 (5): 395-409, 2011.[PUBMED Abstract]
Singh S, Pinsky P, Fineberg NS, et al.: Evaluation of reader variability in the interpretation of follow-up CT scans at lung cancer screening. Radiology 259 (1): 263-70, 2011.[PUBMED Abstract]
Aberle DR, Adams AM, Berg CD, et al.: Baseline characteristics of participants in the randomized national lung screening trial. J Natl Cancer Inst 102 (23): 1771-9, 2010.[PUBMED Abstract]
Park ER, Ostroff JS, Rakowski W, et al.: Risk perceptions among participants undergoing lung cancer screening: baseline results from the National Lung Screening Trial. Ann Behav Med 37 (3): 268-79, 2009.[PUBMED Abstract]
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]
Related PublicationsAberle DR, Berg CD, Black WC, et al.: The National Lung Screening Trial: overview and study design. Radiology 258 (1): 243-53, 2011.[PUBMED Abstract]
Cody DD, Kim HJ, Cagnon CH, et al.: Normalized CT dose index of the CT scanners used in the National Lung Screening Trial. AJR Am J Roentgenol 194 (6): 1539-46, 2010.[PUBMED Abstract]
Clark KW, Gierada DS, Marquez G, et al.: Collecting 48,000 CT exams for the lung screening study of the National Lung Screening Trial. J Digit Imaging 22 (6): 667-80, 2009.[PUBMED Abstract]
Gierada DS, Garg K, Nath H, et al.: CT quality assurance in the lung screening study component of the National Lung Screening Trial: implications for multicenter imaging trials. AJR Am J Roentgenol 193 (2): 419-24, 2009.[PUBMED Abstract]
Trial Lead Organizations
National Cancer Institute
 | | | ||
| Christine Berg, MD, Protocol chair | |
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American College of Radiology Imaging Network
| | | |
| Denise Aberle, MD, Principal investigator | |
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Related Information
Web site for additional information
| Registry Information | ||
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| Official Title | National Lung Screening Trial | |
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| Trial Start Date | 2002-09-18 | |
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| Trial Completion Date | 2010-10-20 | |
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| Registered in ClinicalTrials.gov | NCT00047385 | |
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| Date Submitted to PDQ | 2002-09-13 | |
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| Information Last Verified | 2011-06-23 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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