To identify VOC profiles in exhaled air that are unique for specific liver diseases.
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is to identify VOC profiles in exhaled air that are unique
for specific liver diseases.
Secondary outcome
To compare the VOC profiles in exhaled air between patients with liver diseases
and versus healthy controls.
To compare the VOC profiles before, during and after therapeutic interventions
in various liver diseases (e.g. viral hepatitis, auto-immune hepatitis, NAFLD).
To compare VOC profiles with systemic inflammatory and oxidative stress
markers.
To identify specific metabolites in VOC profiles to gain insight into the
pathogenesis of liver diseases.
Background 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 different pathways of inflammation and oxidative stress and
different metabolic processes are involved in the pathogenesis of liver
diseases. Hence, patients with different liver diseases will form different
metabolites that will be excreted into the breath. 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
diseases, exhaled VOCs have been detected and the presence of differences in
VOC profiles among patients with different liver diseases has been suggested.
We hypothesize that liver diseases with a different pathogenesis and etiology
have different VOC profiles in exhaled air. Therefore, the analysis of VOC
profiles in exhaled air can be useful for the diagnosis and follow-up.
Study objective
To identify VOC profiles in exhaled air that are unique for specific liver
diseases.
Study design
This study is an observational study.
Study burden and risks
No side effects are expected from breath sampling.
No side effects are expected from sampling blood apart from the possible
occurence of a small bruise.
Postbus 5800
6202 AZ Maastricht
NL
Postbus 5800
6202 AZ Maastricht
NL
Listed location countries
Age
Inclusion criteria
- A clearly defined diagnosis of liver diseases based on laboratory, radiological and histological characteristics
- Age between 18 and 85 years
Exclusion criteria
- Inflammatory bowel diseases (IBD)
- Chronic obstructive lung disease (COPD), lung cancer, asthma
- Rheumatoid arthritis (RA)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01279356 |
| CCMO | NL34991.068.10 |