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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
Sponsor:
Information provided by:
Maastricht University Medical Center

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease
Liver Diseases

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
Patients with liver diseases of various etiologies
  • viral hepatitis
  • cholestatic liver diseases
  • auto-immune hepatitis
  • NAFLD
  • ALD
  • sarcoidosis of the liver


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. To compare the VOC profiles in exhaled air between various liver diseases [ Time Frame: 12 months ]
  2. To compare the VOC analysis before, during and after therapeutic interventions in various liver diseases [ Time Frame: 12 months ]
  3. 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

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

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Contact: Kirsten Pijls, MD +31433882157 k.pijls@maastrichtuniversity.nl

Locations
Netherlands
Maastricht University Medical Center, Division of Gastroenterology/Hepatology Not yet recruiting
Maastricht, Limburg, Netherlands
Contact: Kirsten Pijls, MD    +31433882157    k.pijls@maastrichtuniversity.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: A Masclee, MD, PhD Maastricht University Medical Center
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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