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

Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT00012103
Collaborator
National Cancer Institute (NCI) (NIH)
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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
 N/A

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.

Study Design

Study Type:
Interventional
Primary Purpose:
Screening
Official Title:
Prevention and Early Detection of Lung Cancer in Women
Study Start Date :
Sep 1, 1999
Actual Primary Completion Date :
Dec 1, 2001

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NYU School of Medicine's Kaplan Comprehensive Cancer Center New York New York United States 10016

    Sponsors and Collaborators

    • NYU Langone Health
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Abraham Chachoua, MD, NYU Langone Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00012103
    Other Study ID Numbers:
    • CDR0000068484
    • P30CA016087
    • NYU-9928
    • NCI-G01-1913
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Mar 28, 2011
    Last Verified:
    Mar 1, 2011
    Keywords provided by , ,
    non-small cell lung cancer
    small cell lung cancer
    Additional relevant MeSH terms:
    Lung Neoplasms
    Dimercaprol

    Study Results

    No Results Posted as of Mar 28, 2011