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

Prevention and Early Detection of Lung Cancer in Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00012103
Enrollment
Unknown
Registered
2003-01-27
Start date
1999-09-30
Completion date
Unknown
Last updated
2011-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

non-small cell lung cancer, small cell lung cancer

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.

Interventions

PROCEDUREstudy of high risk factors
OTHERbronchoalveolar lavage
PROCEDUREbronchoscopy
PROCEDUREcomputed tomography

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
NYU Langone Health
Lead SponsorOTHER

Study design

Primary purpose
SCREENING

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026