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临床试验/NCT02037828
NCT02037828Unknown不适用

The Screening and Confirmation of Protein Markers Which Can Predict the Decline of Lung Function of Chinese Adults in EBC (Exhaled Breathing Condensate )

Peking University First Hospital1 个研究点 分布在 1 个国家目标入组 2,440 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,440
试验地点
1
主要终点
Protein biomarkers in EBC predicting rapid decline of lung function

研究概览

简要总结

Chronic obstructive lung disease (COPD) is a worldwide leading and still increasing cause of chronic morbidity and mortality. The important issue of COPD is its delayed diagnosis. Previous studies have found that accelerated loss of forced expiratory volume in 1 second (FEV1.0) in an individual is considered an indicator of developing COPD. This functional predictive system, due to lower sensitivity, is very difficult to discover high-risk population and earlier stage of the disease. The inflammation occurs earlier than the lung function impairment. Therefore, early detection of the inflammation may theoretically predict the occurrence of COPD and thus may guide early intervention.

Proteomics techniques and protein chip techniques provides us high throughput screening method to figure out characteristic inflammatory or metabolic markers of a diseases. It can be used for searching the biomarkers relating to lung function loss. EBC is collected from exhaled gas and is a good non-invasive method for exploring the pathologic process of the airways.

Thus we designed this study to identify potential biomarkers associated with rapid lung function decline. This study is divided into two parts: 1) screening potential biomarkers between stable COPD and healthy individuals; 2) verifying significant biomarkers of first part in a community-based nested case-control population for 2 years.

详细描述

Thus we designed this study. This study is divided into two parts: screening target biomarkers and identifying biomarkers.

  1. The FIRST STEP is a Case-control study to find target biomarkers. 20 COPD patients and 20 controls are to be enrolled in the study and their EBC and blood are collected. Proteomics techniques and protein chip techniques are to be used to screen COPD specific biomarkers in EBC.
  2. The SECOND STEP is a community-based nested case-control study to make sure whether the significant biomarkers in first part can predict rapid decline of lung function. The study will be a community based, multicenter prospective cohort designed, which including a total of 2,400 study subjects. EBC and blood are collected at the baseline and followed up for two years. Case group is defined as subjects with rapid decline of lung function and new COPD patients. Control group is selected according to 1:1 matching with age and gender.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Protein biomarkers in EBC predicting rapid decline of lung function

时间窗: 4 years

The study(second part) is to identify the biomarkers screened from the first step and make sure which is associated with rapid decline of lung function. The study will be a community based, multicenter prospective cohort designed, which including a total of 2,400 study subjects.

次要结局

  • Protein biomarkers of EBC between COPD patients and healthy individuals(1 year)
  • Blood biomarkers between COPD patients and healthy individuals(1 year)
  • Blood biomarkers predicting rapid decline of lung function(4 year)

研究者

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

Guangfa Wang

Pro.

Peking University First Hospital

研究点 (1)

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