Clinical trial NCT00012103: Computed Tomography for Early Detection of Cancer in Women Who Are at Risk for Lung Cancer
Official title: Prevention and Early Detection of Lung Cancer in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: non-small cell lung cancer
small cell lung cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SCREENING

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine's Kaplan Comprehensive Cancer Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Abraham Chachoua, MD
role: STUDY_CHAIR
References: