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

NCT ID: NCT00012103

Last Updated: 2011-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-09-30

Brief 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.

Detailed 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.

Conditions

Lung Cancer

Study Design

• Primary Study Purpose: SCREENING

Interventions

bronchoalveolar lavage

Intervention Type: OTHER

screening questionnaire administration

Intervention Type: OTHER

sputum cytology

Intervention Type: OTHER

bronchoscopic and lung imaging studies

Intervention Type: PROCEDURE

bronchoscopy

Intervention Type: PROCEDURE

computed tomography

Intervention Type: PROCEDURE

study of high risk factors

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Principal Investigators

Abraham Chachoua, MD

Role: STUDY_CHAIR

NYU Langone Health

Locations

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

P30CA016087

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NYU-9928

Identifier Type: -

Identifier Source: secondary_id

NCI-G01-1913

Identifier Type: -

Identifier Source: secondary_id

CDR0000068484

Identifier Type: -

Identifier Source: org_study_id