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临床试验/NCT02871856
NCT02871856进行中(未招募)不适用

International Lung Screen Trial

The University of Queensland12 个研究点 分布在 2 个国家目标入组 2,000 人开始时间: 2017年4月5日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
2,000
试验地点
12
主要终点
Change in quality of life

研究概览

简要总结

People who may be at increased risk of lung cancer due to age and smoking history will be invited to participate in this international study to determine the best way of using computed tomography (CT) of the chest to screen for early lung cancer. Overseas data show that CT screening (screening tests can find diseases early, when they're easier to treat) can reduce deaths from lung cancer and this study will help determine who is most likely benefit from screening.

详细描述

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研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
55 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Women or men age from 55 to
  • Current or former smokers. A former smoker is defined as one who has stopped smoking for one or more years.
  • An estimated 6-year lung cancer risk of ≥1.51% based on the PLCOm2012 risk prediction model or ≥ 30 pack-years smoking history (pack-year is defined as number of pack of cigarettes smoked per day multiply by the number of years smoked. If a participant stopped smoking for 6 months or more and then restarted smoking again, the time will be subtracted from the total duration of smoking in 0.5 year increments)
  • ECOG performance status 0 or
  • Capable of providing, informed consent for screening procedures (low dose spiral CT)
  • Exclusion Criteria
  • Clinical symptoms suspicious for lung cancer e.g. hemoptysis, chest pain, weight loss
  • Any medical condition, such as severe heart disease (e.g. unstable angina, chronic congestive heart failure), acute or chronic respiratory failure, home oxygen therapy, bleeding disorder, that in the opinion of the investigator could jeopardize the subject's safety during participation in the study or unlikely to benefit from screening due to shortened life-expectancy from the co-morbidities
  • Have been previously diagnosed with lung cancer
  • Have had other non-curatively treated cancer outside the lung.
  • Pregnancy
  • Pneumonia or bronchitis requiring antibiotic treatment within the last 12 weeks
  • Unwilling to have a spiral chest CT
  • Chest CT within 2 years
  • Does not fit into CT scanner table due to gross obesity
  • Cannot lie on CT scanning table on the back with arms over the head
  • Received chemotherapy or cytotoxic drugs within the last 6 months
  • Unwilling to sign a consent

排除标准

  • 未提供

结局指标

主要结局

Change in quality of life

时间窗: 5 Years

Number of nodules

时间窗: 5 years

The number of Lung cancers

时间窗: 5 years

次要结局

  • Cancer detection rate(5 years)
  • Types and number of investigations(5 Years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kwun Fong

Professor

The University of Queensland

研究点 (12)

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