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

NYU Langone Health

Status

Completed

Conditions

Lung Cancer

Treatments

Other: bronchoalveolar lavage

Other: sputum cytology

Procedure: study of high risk factors

Procedure: bronchoscopy

Other: screening questionnaire administration

Procedure: computed tomography

Procedure: bronchoscopic and lung imaging studies

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00012103

NCI-G01-1913

CDR0000068484

NYU-9928

P30CA016087 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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