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临床试验/NCT04419207
NCT04419207已完成不适用

Detecting Lung Cancer by Volatile Organic Compounds in Exhaled Breath: a Study of Lung Cancer Diagnostic Biomarker

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 2,236 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,236
试验地点
1
主要终点
Positive predictive value of exhaled breath

研究概览

简要总结

Early detection is critical to improve the overall survival of lung cancer. Endogenous volatile organic compounds (VOCs) can be derived from many different metabolic pathways. On the other hand, cancer cells have different metabolism patterns compared with normal cells. Thus, detecting VOCs in exhaled breath using highly sensitive mass spectrometry would be a promising approach for lung cancer detection.

详细描述

Endogenous volatile organic compounds (VOCs) can be derived from many different metabolic pathways. VOCs can be transported to the alveoli through the blood circulation and expelled by exhalation. Changes in VOCs production, clearance, and alterations in lung air-blood exchange functions can lead to aberrant VOCs profiles in the exhaled breath. Testing exhaled breath has the advantages of being completely non-invasive and easy to collect, and has been considered as a perfect approach for disease diagnoses and therapeutic monitoring. Many clinical studies have found that VOCs in exhaled breath are closely related to disease status. Specific VOCs alterations have been identified in many tumors, especially lung cancer.

In this study, we use a highly sensitive mass spectrometry to detect exhaled VOCs of lung cancer patients and healthy people. A lung cancer diagnosis model based on mass spectrometry data and support vector machine will be initially established and validated.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • history of malignant tumors.
  • receive anti-tumor treatment such as radiotherapy, chemotherapy, targeted therapy before surgery
  • with infections or liver disease

结局指标

主要结局

Positive predictive value of exhaled breath

时间窗: 2 year

Using pathologic diagnosis of lung cancer as gold standard, positive predictive value of exhaled breath will be calculated

Negative predictive value of exhaled breath

时间窗: 2 year

Using pathologic diagnosis of lung cancer as gold standard, negative predictive value of exhaled breath will be calculated

Diagnostic sensitivity of exhaled breath

时间窗: 2 year

Using pathologic diagnosis of lung cancer as gold standard, diagnostic sensitivity of exhaled breath will be calculated

Diagnostic accuracy of exhaled breath

时间窗: 2 year

Using pathologic diagnosis of lung cancer as gold standard, diagnostic accuracy of exhaled breath will be calculated

Diagnostic specificity of exhaled breath

时间窗: 2 year

Using pathologic diagnosis of lung cancer as gold standard, diagnostic specificity of exhaled breath will be calculated

次要结局

未报告次要终点

研究者

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

zhouzuli

M.D.,Department of Thoracic Surgery

Peking University People's Hospital

研究点 (1)

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