- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006382
Lung Screening Study
RATIONALE: New imaging procedures such as spiral CT may improve the ability to detect lung cancer in patients who are at high risk for the disease.
PURPOSE: Randomized clinical trial to compare the effectiveness of a spiral CT scan with that of a chest x-ray in detecting lung cancer in patients who are at high risk for the disease.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES: I. Compare the efficacy of screening spiral CT scan and screening chest x-ray in detecting lung cancer in current or former smokers at high risk for lung cancer.
OUTLINE: This is a randomized, multicenter study of lung cancer screening. Patients are randomized to one of two screening arms. Arm I: Patients undergo one spiral CT scan. Arm II: Patients undergo one chest x-ray. Patients and their primary care physicians are notified of test results within 3 weeks of the exam.
PROJECTED ACCRUAL: A total of 3,000 participants (1,500 per screening arm) will be accrued for this study at six screening centers (500 per center) by October 31, 2000.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama Comprehensive Cancer Center
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Vincent T. Lombardi Cancer Research Center, Georgetown University
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Cancer Center
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Wisconsin
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Marshfield, Wisconsin, United States, 54449
- Marshfield Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: See General Eligibility Criteria
PATIENT CHARACTERISTICS: Age: 55 to 74 Patients with a cigarette smoking history of at least 30 pack-years Current smoker OR Smoker who has quit smoking within the past 10 years No known prior history of lung cancer
PRIOR CONCURRENT THERAPY: No concurrent therapy for any cancer except nonmelanomatous skin cancer No prior removal of any portion of the lungs No concurrent participation in other cancer screening trial, including PLCO No concurrent participation in a primary cancer prevention trial other than a smoking cessation trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: John K. Gohagan, PhD, FACE, National Cancer Institute (NCI)
Publications and helpful links
General Publications
- Croswell JM, Baker SG, Marcus PM, Clapp JD, Kramer BS. Cumulative incidence of false-positive test results in lung cancer screening: a randomized trial. Ann Intern Med. 2010 Apr 20;152(8):505-12, W176-80. doi: 10.7326/0003-4819-152-8-201004200-00007. Erratum In: Ann Intern Med. 2010 Jun 1;152(11):759.
- Gohagan J, Marcus P, Fagerstrom R, Pinsky P, Kramer B, Prorok P; Writing Committee, Lung Screening Study Research Group. Baseline findings of a randomized feasibility trial of lung cancer screening with spiral CT scan vs chest radiograph: the Lung Screening Study of the National Cancer Institute. Chest. 2004 Jul;126(1):114-21. doi: 10.1378/chest.126.1.114.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000068258
- NCI-LUNG
- NCI-P00-0171
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