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Prevention and Early Detection of Lung Cancer in Women
RATIONALE: Imaging procedures such as computed tomography may improve the ability to detect lung cancer earlier. PURPOSE: Screening and diagnostic study of computed tomography in women who are at risk for lung cancer.
OBJECTIVES: * Determine the ability of computed tomography (CT) to detect early lung parenchymal abnormalities in women at high risk for lung cancer. * Determine the number of abnormal findings detected by CT that develop into lung cancer in these patients. * Correlate these abnormalities with the presence of K-ras and p53 mutations in the sputum and bronchoalveolar lavage in these patients. * Develop and implement appropriate educational materials regarding lung cancer in women and provide referrals to other programs, such as smoking cessation programs. OUTLINE: Patients complete a questionnaire at baseline to assess demographics, medical history, smoking history, menopausal status, estrogen therapy, and diet. Patients then undergo a low-dose computed tomography (CT) scan without contrast. Patients with normal CT results undergo additional CT scans every 12 months. Patients with abnormal CT results undergo a diagnostic CT scan (in the absence of prior studies). Patients with indeterminate nodules (less than 5 mm in size) undergo surveillance CT studies within 3-4 months. If nodules remain unchanged in size, patients undergo additional surveillance CT studies at 6 months and 1 year. Patients with lung parenchymal abnormalities on CT suspicious for malignancy undergo a bronchoscopy with biopsy and bronchoalveolar lavage (BAL). Patients with abnormal CT scan(s) and negative BAL for p53 and/or K-ras mutations or normal histology and positive BAL for K-ras and/or p53 mutations undergo additional CT scans at 6 months and 1 year. Patients with biopsy-proven malignancy after bronchoscopy are referred for definitive treatment. PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States
Start Date
September 1, 1999
Primary Completion Date
December 1, 2001
Last Updated
March 28, 2011
bronchoalveolar lavage
OTHER
screening questionnaire administration
OTHER
sputum cytology
OTHER
bronchoscopic and lung imaging studies
PROCEDURE
bronchoscopy
PROCEDURE
computed tomography
PROCEDURE
study of high risk factors
PROCEDURE
Lead Sponsor
NYU Langone Health
Collaborators
NCT06498635
NCT05198830
Data Source & Attribution
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