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临床试验/NCT01279356
NCT01279356Unknown不适用

Analysis of Volatile Organic Compounds in Exhaled Air as a Non-invasive Biomarker for Liver Diseases

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
160
试验地点
1
主要终点
To establish the validity of VOC analysis in exhaled air to discriminate between liver diseases and non-diseased controls

研究概览

简要总结

Liver diseases such as non-alcoholic fatty liver disease (NAFLD), alcoholic liver disease (ALD) and viral hepatitis have the potential to progress to cirrhosis and finally hepatocellular carcinoma (HCC). Early diagnosis and treatment of liver diseases is important since progression is likely and is associated with significant morbidity and mortality. However, in daily clinical practice no specific and non-invasive biomarkers are used for the diagnosis and follow-up of patients with liver diseases. It is known that patients with liver diseases produce compounds that can be excreted in breath as a consequence of metabolic processes, inflammation and/or oxidative stress. These are called volatile organic compounds (VOCs). Analysis of VOCs in exhaled air has been reported to provide valuable information in patients with chronic obstructive lung disease (COPD) and inflammatory bowel disease (IBD). Also, in patients with liver disease, exhaled VOCs have been detected.

The investigators hypothesize that analysis of VOCs in exhaled air of patients with liver diseases can be used for diagnosis and follow-up.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Established diagnosis of liver diseases based on laboratory, radiological and histological characteristics
  • Age between 18 and 85 years

排除标准

  • Inflammatory bowel disease
  • Chronic obstructive lung disease, lung cancer, asthma
  • Rheumatoid arthritis

结局指标

主要结局

To establish the validity of VOC analysis in exhaled air to discriminate between liver diseases and non-diseased controls

时间窗: 12 months

次要结局

  • To compare the VOC analysis before, during and after therapeutic interventions in various liver diseases(12 months)
  • To compare the VOC profiles in exhaled air between various liver diseases(12 months)
  • To compare VOC profiles with systemic inflammatory and oxidative stress markers(12 months)

研究者

申办方类型
Other

研究点 (1)

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