Trial Information

Prevention and Early Detection of Lung Cancer in Women

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.