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Prevention and Early Detection of Lung Cancer in Women


N/A
18 Years
N/A
Not Enrolling
Female
Lung Cancer

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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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Screening

Principal Investigator

Abraham Chachoua, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine

Authority:

United States: Federal Government

Study ID:

CDR0000068484

NCT ID:

NCT00012103

Start Date:

September 1999

Completion Date:

Related Keywords:

  • Lung Cancer
  • non-small cell lung cancer
  • small cell lung cancer
  • Lung Neoplasms

Name

Location

NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016