Computed Tomography for Early Detection of Cancer in Women Who Are at Risk for Lung Cancer

Lung Cancer Clinical Trial

Official title: Prevention and Early Detection of Lung Cancer in Women

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

• NCT number: NCT00012103
• Study type: Interventional
• Source: New York University School of Medicine
• Status: Completed
• Phase: N/A
• Start date: September 1999