Chest X-Ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer
|ClinicalTrials.gov Identifier: NCT00006087|
Recruitment Status : Unknown
Verified December 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : December 23, 2003
Last Update Posted : February 9, 2009
RATIONALE: Diagnostic procedures such as chest x-ray and chest CT scans may be effective in early detection of lung cancer.
PURPOSE: Randomized clinical trial to compare the effectiveness of a chest CT scan given once a year with that of a chest x-ray given once a year in detecting lung cancer in patients at a high-risk of developing lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Procedure: annual screening Procedure: bronchoscopic and lung imaging studies Procedure: comparison of screening methods Procedure: computed tomography Procedure: radiography Procedure: study of high risk factors||Not Applicable|
OBJECTIVES: I. Determine the efficacy of a lung cancer risk assessment questionnaire combined with spirometry testing in identifying a statistically significant number of persons with high-risk behaviors for the development of lung cancer. II. Determine the sensitivity of these screening techniques in identifying a population at high risk for the development of lung cancer. III. Determine the number of patients necessary to screen in order to identify the high-risk population eligible for this study. IV. Determine the lead time bias of CT scans versus chest x-rays in these patients. V. Determine the efficacy of spiral CT scanning of the chest in detecting early lung cancers not visible on chest x-rays in patients at high risk for lung cancer. VI. Compare annual spiral CT scanning versus annual chest x-rays in detecting lung cancer in these patients. VII. Compare survival and fatality in these patients with these detection methods.
OUTLINE: Patients are randomized to one of two screening arms. Arm I: Patients receive routine medical care, an annual nursing assessment, and an annual chest x-ray. Any new abnormality identified is further evaluated through standard acceptable medical interventions. Arm II: Patients receive routine medical care, an annual nursing assessment, and an annual spiral CT scan of the chest. If an abnormal mass greater than 10 mm in diameter or 5-10 mm in diameter and highly suspicious for malignancy is detected, chest x-ray and tissue diagnosis is obtained. If the abnormal mass is 10 mm or less in diameter, a thin section high resolution image of the mass is obtained. If this image is normal or benign, annual spiral CT scanning is continued. If the image is indeterminate, a repeat high resolution scan is performed in 3 months. If the image is unchanged at 3 months, annual spiral CT scanning is continued. If the mass is larger at 3 months, chest x-ray and tissue diagnosis is performed. Screening continues for 5 years in the absence of disease detection.
PROJECTED ACCRUAL: A minimum of 1,000 patients (500 per screening arm) will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Randomized Prospective Study Comparing Annual Chest X-Rays to Annual Spiral Chest CT Scanning in Patients at High-Risk for the Development of Lung Cancer|
|Study Start Date :||November 1999|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006087
|United States, Kentucky|
|Louisville, Kentucky, United States, 40202-1886|
|Study Chair:||Renato V. LaRocca, MD, FACP||Kentuckiana Cancer Institute, PLLC|