Volatile Organic Compounds (VOCs) and Liver Diseases

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01279356
• Other study ID #: MEC 10-3-088
• Status: Not yet recruiting
• Phase: N/A
• First received: January 17, 2011
• Last updated: January 27, 2011
• Start date: February 2011
• Est. completion date: August 2012

Study information

• Verified date: January 2011
• Source: Maastricht University Medical Center
• Contact: Kirsten Pijls, MD
• Phone: +31433882157
• Email: k.pijls[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: August 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Diseases

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center, Division of Gastroenterology/Hepatology	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish the validity of VOC analysis in exhaled air to discriminate between liver diseases and non-diseased controls		12 months	No
Secondary	To compare the VOC profiles in exhaled air between various liver diseases		12 months	No
Secondary	To compare the VOC analysis before, during and after therapeutic interventions in various liver diseases		12 months	No
Secondary	To compare VOC profiles with systemic inflammatory and oxidative stress markers		12 months	No