Diagnostic Imaging |
CAT Scan; Computed Tomography; CT; Nuclear Medicine Tests; Radionuclide Scans |
Clinical Trial: Computed Tomography for Early Detection of Cancer in Women Who Are at Risk for Lung Cancer
This study is no longer recruiting patients.
Purpose
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.
| Condition | Treatment or Intervention |
|---|---|
| Non-small cell lung cancer Small Cell Lung Cancer | Procedure: bronchoalveolar lavage Procedure: bronchoscopic and lung imaging studies Procedure: bronchoscopy Procedure: computed tomography Procedure: diagnostic test Procedure: screening intervention Procedure: screening questionnaire Procedure: sputum cytology Procedure: study of high risk factors |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Lung Cancer
Study Type: Observational
Study Design: Screening
Official Title: Screening and Diagnostic Study of Computerized Tomography in Women at High Risk for Lung Cancer
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
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
Location Information
New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, 10016, United States
Abraham Chachoua, MD, Study Chair, Kaplan Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: March 2004
Last Updated: October 13, 2004
Record first received: March 3, 2001
ClinicalTrials.gov Identifier: NCT00012103
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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