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


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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.

Sponsors and Collaborators: Kaplan Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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

Further Study Details: 

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:

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

Study chairs or principal investigators

Abraham Chachoua, MD,  Study Chair,  Kaplan Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068484; NYU-9928; NCI-G01-1913
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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October 13, 2008



Page Updated: October 3, 2005
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