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
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|
|Study Type :||Observational|
|Estimated Enrollment :||160 participants|
|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|
Patients with liver diseases of various etiologies
- 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
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, MDfirstname.lastname@example.org|
|Maastricht University Medical Center, Division of Gastroenterology/Hepatology|
|Maastricht, Limburg, Netherlands|
|Contact: Kirsten Pijls, MD +31433882157 email@example.com|
|Principal Investigator:||A Masclee, MD, PhD||Maastricht University Medical Center|