Computed Tomography for Early Detection of Cancer in Women Who Are at Risk for Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00012103|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 28, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Other: bronchoalveolar lavage Other: screening questionnaire administration Other: sputum cytology Procedure: bronchoscopic and lung imaging studies Procedure: bronchoscopy Procedure: computed tomography Procedure: study of high risk factors||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Prevention and Early Detection of Lung Cancer in Women|
|Study Start Date :||September 1999|
|Actual Primary Completion Date :||December 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|