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临床试验/NCT02693496
NCT02693496招募中不适用

Mobile Lung Nodule Observatory for Worldwide, Evidenced - Based Research

Chinese Alliance Against Lung Cancer34 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10,000
试验地点
34
主要终点
To compare the diagnostic accuracy among different type of lung nodules.

研究概览

简要总结

Patients with lung nodules may develop a variety of potentially severe symptoms. These symptoms may impact a patient's quality of life and lead to difficult treatment. Through this research program, the investigators want to understand the pathogenesis of the changes of these symptoms.

详细描述

Lung nodules can manifest as single or multiple independent lung consolidation shadow in form of quasi-circular. These lung nodules are surrounded by normal lung tissues, and will not cause pulmonary atelectasis. In some early standards, all the quasi-circular shadows within 6cm found in lung are categorized as lung nodules. However, according to current standards, the lesion within 3cm can be identified as lung nodules. With widespread use of lung cancer CT screening, lung nodules were identified more and more frequently.

What is the optimal way to manage this CT finding? Should we adopt surgical removal or just observation? An optimal solution is to determine a clearly defined standard of care that is easy to learn. We propose a method called "three plus two". The 'Three' is a three-step testing method, and the 'Two' means two alternative solutions. Three-step testing method includes collecting medical history, non-invasive examination, and invasive examination. The two alternative solutions are surgical removal and follow-up observation. We have independently developed an application based on a smartphone platform. This platform will provide a novel evidence-based research method for observing the dynamic evolution of the lung nodules in patients. There have been no prior studies about managing this CT scan finding, either in China or internationally.

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
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 90
  • There is a chest lesion less than 3cm width (examined by Thin-Section CT)
  • The patient or his family member owns a smartphone
  • Signed informed consent
  • Completed the installation and registration of mobile terminal software online
  • Willing to complete a 10-year period of follow-up

排除标准

  • Not equipped with a smartphone
  • Cannot complete the installation or registration of smartphone application software online
  • Received prior chemotherapy medications for lung cancer or received lung surgical removal treatment

结局指标

主要结局

To compare the diagnostic accuracy among different type of lung nodules.

时间窗: 10 years

Utilizing the professional statistical software (SPSS 15.0), through T-test, Mann-Whitney U test, and analyzing the receiver operating characteristic (ROC) curve, to compare the diagnostic accuracy among different type of lung nodules. A p\<0.05 cutoff will be the standard used to determine statistical significance.

次要结局

未报告次要终点

研究者

发起方
Chinese Alliance Against Lung Cancer
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bai Chunxue

Professor

Chinese Alliance Against Lung Cancer

研究点 (34)

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