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Sponsors and Collaborators: |
American College of Radiology Imaging Network National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00028808 |
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 computed tomography is more effective than chest x-ray in detecting lung cancer.
PURPOSE: Randomized clinical trial to compare the effectiveness of helical computed tomography with that of chest x-ray in screening individuals who are at high risk for lung cancer.
Condition | Intervention |
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Lung Cancer |
Procedure: comparison of screening methods Procedure: computed tomography Procedure: radiography Procedure: study of high risk factors |
Study Type: | Interventional |
Study Design: | Screening, Randomized, Active Control |
Official Title: | Contemporary Screening for the Detection of Lung Cancer |
Study Start Date: | July 2002 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Participants are randomized to 1 of 2 screening arms.
Participants undergo spirometry at baseline for assessment of risk profile.
Quality of life is assessed at baseline, 1 month after the screening test, and then every 6 months for up to 6-8 years.
Health status and medical resource utilization are assessed every 6-12 months for up to 6-8 years.
PROJECTED ACCRUAL: A total of 50,000 participants will be accrued for this study within 2 years.
Ages Eligible for Study: | 55 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No concurrent symptoms suggestive of lung cancer, including the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
No cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Denise R. Aberle, MD | Jonsson Comprehensive Cancer Center |
Study Chair: | John K. Gohagan, PhD, FACE | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000069136, ACRIN-6654, NCI-ACRIN-6654 |
Study First Received: | January 4, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00028808 |
Health Authority: | United States: Federal Government |
small cell lung cancer non-small cell lung cancer |
Thoracic Neoplasms Carcinoma, Small Cell Non-small cell lung cancer Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site |