Expired Study
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New York, New York 10016


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: - Women who currently smoke or have smoking history of at least a 30 pack year - Pack year is defined by the number of pack(s) of cigarettes per day times the number of years of smoking - No history of prior lung cancer PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No prior cancer within the past 5 years except basal cell or superficial skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified


NCT ID:

NCT00012103


Primary Contact:

Study Chair
Abraham Chachoua, MD
New York University School of Medicine


Backup Contact:

N/A


Location Contact:

New York, New York 10016
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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