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临床试验/NCT00188890
NCT00188890已完成不适用

Early Diagnosis of Mesothelioma and Lung Cancer Following Asbestos Exposure Using Low-dose Computed Tomography

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 1,452 人开始时间: 2005年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,452
试验地点
1

研究概览

简要总结

Occupational exposure to asbestos is known increase the risk of developing cancer of the lungs (bronchogenic carcinoma) or of the pleura (mesothelioma). Symptoms are subtle and non-specific, diagnosis is often late and the prognosis consequently is dismal. Currently there is no accepted non-invasive tool for the early diagnosis of mesothelioma or lung cancer in asbestos-exposed subjects. In the last decade, low-dose computed tomography (LDCT) has been successfully developed and validated for the early diagnosis of lung cancer in high-risk smokers. Malignant mesothelioma might, in an early stage, resemble a benign pleural plaque, which is a common finding after asbestos exposure. We target to develop low-dose CT as a tool to serially image the pleural plaques, quantify their individual and overall volume, compute the growth rate with time, and, as such, identify the presence of mesothelioma early, before symptoms occur.

详细描述

Background and Purpose:

Asbestos exposure may result in several different diseases to the lung and to the lining of the lung, the so-called pleura. Mostly they are benign, but there are two common malignant diseases in people with prior asbestos exposure, the so-called mesothelioma - which originates from the pleura - and cancer of the lung. Symptoms of any of these malignant diseases generally do not appear for 10-35 years after the first asbestos exposure, and include shortness of breath, chronic or new cough, coughing of blood, chest pain or weight loss. Unfortunately, these symptoms are most often causes by very advanced diseases, when patients can no longer be cured. Currently there is no accepted tool for the early diagnosis of mesothelioma or lung cancer in asbestos-exposed subjects available. Standard of care includes regular chest radiographs, which are not sufficient to show mesothelioma or lung cancer in an early stage.

A screening CT examination, also called CAT scan, of the lungs will be performed without intravenous contrast. The CT examination as such is not an experimental procedure, CAT scans are performed routinely since decades. However, in this particular case, this albeit standard examination is performed for the purposes of research only, it is not part of standard of care. The screening CT examination of the lungs takes less than 10-20 minutes to perform.

If no abnormalities are found on the initial examinations, you will be examined with one repeat screening CT of the chest after one year.

If pleural plaques or a nodule in the lungs is seen on your baseline CT, this will lead to further testing. Quite likely (approximately 1 in 3 chance), you will be invited for a follow-up CT 3 or 6 months. Further investigations will be chosen according to standard of care and will be explained to you at the time. These will be coordinated by your physician with Dr. Marc de Perrot, Department of Thoracic Surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • prior asbestos exposure at least 20 years ago and/or documented pleural plaques (chest x-ray evidence)
  • Resident of Ontario, Canada

排除标准

  • prior cancer (except non-melanotic skin cancer)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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