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Computed Tomography for Early Detection of Cancer in Women Who Are at Risk for Lung Cancer
This study is ongoing, but not recruiting participants.
Study NCT00012103   Information provided by National Cancer Institute (NCI)
First Received: March 3, 2001   Last Updated: February 6, 2009   History of Changes

March 3, 2001
February 6, 2009
September 1999
 
 
 
Complete list of historical versions of study NCT00012103 on ClinicalTrials.gov Archive Site
 
 
 
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

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.

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.

 
Interventional
Screening
Lung Cancer
  • Other: bronchoalveolar lavage
  • Other: screening questionnaire administration
  • Other: sputum cytology
  • Procedure: bronchoscopic and lung imaging studies
  • Procedure: bronchoscopy
  • Procedure: computed tomography
  • Procedure: study of high risk factors
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00012103
 
CDR0000068484, NYU-9928, NCI-G01-1913
New York University School of Medicine
National Cancer Institute (NCI)
Study Chair: Abraham Chachoua, MD New York University School of Medicine
National Cancer Institute (NCI)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP