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临床试验/NCT03976804
NCT03976804Unknown不适用

Epidemiological Study to Assess the Prevalence of Lung Cancer in Patients With Smocking-associated Atherosclerotic Cardiovascular Diseases

Centre Chirurgical Marie Lannelongue2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年11月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
2
主要终点
prevalence of lung cancer

研究概览

简要总结

Lung cancer is the main cause of mortality by cancer in France. The lung cancer stage at time of diagnosis is a major determinant of survival. To date, 75% of lung cancer are diagnosed at an advanced stage with worse survival). Lung cancer screening is based on low dose CT scan which allows to decrease lung cancer related mortality of 20% in patients aged 55-74 years-old with a history of tobacco consumption ≥ 30 PY active of who quite < 15 years. These criteria for eligibility for lung cancer screening lead to 1 to 2% of lung cancer diagnosis at the first CT scan. In our experience regarding 1 year of lung cancer surgical resection, only 45% of the patients presented criteria for lung cancer screening. Moreover, the duration of tobacco consumption would provide a better stratification of lung cancer risk compared to only PY. Therefore, other criteria for lung cancer screening eligibility could be proposed. Currently, 9 out of 10 lung cancer is linked with tobacco consumption which is also a major risk factor for atherosclerosis-associated cardiovascular events. Around 40% of patients with a lung cancer have a history of atherosclerosis-associated cardiovascular event, mainly coronary artery diseases and peripheral artery diseases. Main Objective: The objective is to compare the observed rate of lung cancer prevalence in our study to the rate of around 2 % observed in lung cancer screening trials in south Europe (France and Italy).

The investigators hypothesize that the population of patients with a history of atherosclerotic cardiovascular event associated with tobacco consumption present a higher prevalence of lung cancer compared with the population of patients eligible for lung cancer screening program which is defined by age and history of tobacco consumption.

研究设计

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

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 45 - 75 years old
  • Patient who has signed an informed written consent
  • Daily smoking for at least 10 years
  • History of cardiovascular disease:

排除标准

  • History of active cancer < 5 years (except in situ cervical carcinoma and basal cell carcinoma of the skin)
  • Lung cancer symptoms (involuntary weight loss > 6.8 kg in 1 year, hemoptysis)
  • Treatment or bleeding risk syndrome contraindicating an invasive diagnostic procedure within 3 months.
  • Active pulmonary parenchymal infection
  • Severe cardiac or respiratory insufficiency (resting dyspnea)

结局指标

主要结局

prevalence of lung cancer

时间窗: 19 months

estimation of the prevalence of lung cancer among patients managed for atherosclerosis-related cardiovascular events associated with tobacco consumption.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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