Volatile Organic Compounds (VOCs) and Liver Diseases

• Conditions: Liver Diseases

• Registration Number: NCT01279356
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-01
• Study First Submitted: 2011-01-17
• Study First Submitted QC: 2011-01-18
• Study First Posted: 2011-01-19
• Last Update Submitted: 2011-01-27
• Last Update Posted: 2011-01-28
• Study Start: 2011-02
• Primary Completion: 2012-02
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To establish the validity of VOC analysis in exhaled air to discriminate between liver diseases and non-diseased controls	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Maastricht University Medical Center, Division of Gastroenterology/Hepatology; 🇳🇱 Maastricht, Limburg, Netherlands