Computed Tomography for Early Detection of Cancer in Women Who Are at Risk for Lung Cancer
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.
Other: bronchoalveolar lavage
Other: screening questionnaire administration
Other: sputum cytology
Procedure: bronchoscopic and lung imaging studies
Procedure: computed tomography
Procedure: study of high risk factors
|Study Design:||Primary Purpose: Screening|
|Official Title:||Prevention and Early Detection of Lung Cancer in Women|
|Study Start Date:||September 1999|
|Primary Completion Date:||December 2001 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00012103
|United States, New York|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|Study Chair:||Abraham Chachoua, MD||New York University School of Medicine|