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临床试验/NCT00012103
NCT00012103已完成不适用

Prevention and Early Detection of Lung Cancer in Women

NYU Langone Health1 个研究点 分布在 1 个国家开始时间: 1999年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
主要目的
Screening

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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:
  • •Performance status:
  • •Life expectancy:
  • •Not specified
  • •Hematopoietic:
  • •Not specified
  • •Not specified
  • •Not specified
  • •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
  • •Not specified

排除标准

  • 未提供

研究者

申办方类型
Other

研究点 (1)

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