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Volatile Organic Compounds (VOCs) and Liver Diseases

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by Maastricht University Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by:
Maastricht University Medical Center Identifier:
First received: January 17, 2011
Last updated: January 27, 2011
Last verified: January 2011

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.

Liver Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Volatile Organic Compounds in Exhaled Air as a Non-invasive Biomarker for Liver Diseases

Resource links provided by NLM:

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • To establish the validity of VOC analysis in exhaled air to discriminate between liver diseases and non-diseased controls [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • 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
The following biospecimens will be collected: exhaled air and plasma/serum

Estimated Enrollment: 160
Study Start Date: February 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Patients with liver diseases of various etiologies
  • viral hepatitis
  • cholestatic liver diseases
  • auto-immune hepatitis
  • ALD
  • sarcoidosis of the liver


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
Study Population
The study population will include patients with various liver diseases visiting the outpatient clinic.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01279356

Contact: Kirsten Pijls, MD +31433882157

Maastricht University Medical Center, Division of Gastroenterology/Hepatology Not yet recruiting
Maastricht, Limburg, Netherlands
Contact: Kirsten Pijls, MD    +31433882157   
Sponsors and Collaborators
Maastricht University Medical Center
Principal Investigator: A Masclee, MD, PhD Maastricht University Medical Center
  More Information

Responsible Party: Prof. dr. A. Masclee, Maastricht University Medical Center Identifier: NCT01279356     History of Changes
Other Study ID Numbers: MEC 10-3-088
Study First Received: January 17, 2011
Last Updated: January 27, 2011

Keywords provided by Maastricht University Medical Center:
Liver diseases
Volatile organic compounds
Oxidative stress
non-invasive tests

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases processed this record on September 21, 2017