跳至主要内容
临床试验/NCT04948047
NCT04948047Unknown不适用

Assessment of the Efficacy of Breath Test Combined With Computed Tomography for Diagnoses of Pulmonary Nodules.

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2021年7月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
900
试验地点
1
主要终点
Diagnostic sensitivity of breath test combined with computed tomography

研究概览

简要总结

Pulmonary nodules diagnosis using breath test of volatile organic compound (VOC) is in its infancy. The accuracy of VOC analysis in diagnosing malignant pulmonary nodules varies cross the published studies. The diagnosis accuracy of VOC alone is generally poor. We speculate that the accuracy of diagnosing malignant pulmonary nodules will be improved by combining breath test with chest computed tomography (CT). This study aims to establish a predictive model of malignant pulmonary nodule using bio-markers from exhaled breath and image-markers from chest CT with retrospective data from multi centers. The sensitivity, specificity and accuracy of the model will be validated prospectively.

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. Pulmonary nodules diagnosis using breath test of volatile organic compound (VOC) is in its infancy. The accuracy of VOC analysis in diagnosing malignant pulmonary nodules varies cross the published studies. The diagnosis accuracy of VOC alone is generally poor. We speculate that the accuracy of diagnosing malignant pulmonary nodules will be improved by combining VOC analysis with chest computed tomography.

In this study, we use a highly sensitive mass spectrometry to detect exhaled VOCs of patients with pulmonary nodules. The chest CT will be used for detecting the imaging characteristics of pulmonary nodules. The pathological diagnosis of pulmonary nodules after surgical resections is selected as golden standard.

This study aims to establish a predictive model of malignant pulmonary nodule using bio-markers from breath test and image-markers from chest CT with retrospective data from multi centers. The sensitivity, specificity and accuracy of the model will be varied prospectively.

研究设计

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

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

  • Age > 18 years old;
  • Pulmonary nodules with planned surgical resection;
  • Signed informed consent and agreed to participate in this study.

排除标准

  • Preoperative radiotherapy, chemotherapy, targeted therapy or other anti-tumor therapy
  • The lack of chest computed tomography within two weeks before surgery
  • A history of malignant disease within 5 years.

结局指标

主要结局

Diagnostic sensitivity of breath test combined with computed tomography

时间窗: 8 weeks

Using pathological diagnosis of pulmonary nodule as gold standard, diagnostic specificity of breath test combined with computed tomography will be calculated

Diagnostic specificity of breath test combined with computed tomography

时间窗: 8 weeks

Using pathological diagnosis of pulmonary nodule as gold standard, diagnostic specificity of breath test combined with computed tomography will be calculated

Diagnostic accuracy of breath test combined with computed tomography

时间窗: 8 weeks

Using pathological diagnosis of pulmonary nodule as gold standard, diagnostic accuracy of breath test combined with computed tomography will be calculated

次要结局

  • Negative predictive value of breath test combined with computed tomography(8 weeks)
  • Positive predictive value of breath test combined with computed tomography(8 weeks)

研究者

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

Mantang Qiu, MD, PhD

Research Assistant

Peking University People's Hospital

研究点 (1)

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