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

Sponsor:

ClinicalTrials.gov Identifier:

NCT01279356

First Posted: January 19, 2011

Last Update Posted: January 28, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Maastricht University Medical Center

Purpose

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
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:

MedlinePlus related topics: Liver Diseases

U.S. FDA Resources

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)

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

Eligibility

Information from the National Library of Medicine

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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

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


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 Submitted:	January 17, 2011
First Posted:	January 19, 2011
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

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