Volatile Organic Compounds (VOCs) and Liver Diseases
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ClinicalTrials.gov Identifier: NCT01279356 |
Recruitment Status
: Unknown
Verified January 2011 by Maastricht University Medical Center.
Recruitment status was: Not yet recruiting
First Posted
: January 19, 2011
Last Update Posted
: January 28, 2011
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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.
Condition or disease |
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Liver Diseases |
Study Type : | Observational |
Estimated Enrollment : | 160 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Analysis of Volatile Organic Compounds in Exhaled Air as a Non-invasive Biomarker for Liver Diseases |
Study Start Date : | February 2011 |
Estimated Primary Completion Date : | February 2012 |
Estimated Study Completion Date : | August 2012 |

Group/Cohort |
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Patients with liver diseases of various etiologies
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- To establish the validity of VOC analysis in exhaled air to discriminate between liver diseases and non-diseased controls [ Time Frame: 12 months ]
- To compare the VOC profiles in exhaled air between various liver diseases [ Time Frame: 12 months ]
- To compare the VOC analysis before, during and after therapeutic interventions in various liver diseases [ Time Frame: 12 months ]
- To compare VOC profiles with systemic inflammatory and oxidative stress markers [ Time Frame: 12 months ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279356
Contact: Kirsten Pijls, MD | +31433882157 | k.pijls@maastrichtuniversity.nl |
Netherlands | |
Maastricht University Medical Center, Division of Gastroenterology/Hepatology | Not yet recruiting |
Maastricht, Limburg, Netherlands | |
Contact: Kirsten Pijls, MD +31433882157 k.pijls@maastrichtuniversity.nl |
Principal Investigator: | A Masclee, MD, PhD | Maastricht University Medical Center |
Responsible Party: | Prof. dr. A. Masclee, Maastricht University Medical Center |
ClinicalTrials.gov Identifier: | NCT01279356 History of Changes |
Other Study ID Numbers: |
MEC 10-3-088 |
First Posted: | January 19, 2011 Key Record Dates |
Last Update Posted: | January 28, 2011 |
Last Verified: | January 2011 |
Keywords provided by Maastricht University Medical Center:
Liver diseases Volatile organic compounds Inflammation Oxidative stress non-invasive tests |
Additional relevant MeSH terms:
Liver Diseases Digestive System Diseases |