Volatile Organic Compounds (VOCs) and Liver Diseases

January 27, 2011 updated by: Maastricht University Medical Center

Analysis of Volatile Organic Compounds in Exhaled Air as a Non-invasive Biomarker for Liver Diseases

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands
        • Maastricht University Medical Center, Division of Gastroenterology/Hepatology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare the VOC profiles in exhaled air between various liver diseases
Time Frame: 12 months
12 months
To compare the VOC analysis before, during and after therapeutic interventions in various liver diseases
Time Frame: 12 months
12 months
To compare VOC profiles with systemic inflammatory and oxidative stress markers
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ANTICIPATED)

February 1, 2012

Study Completion (ANTICIPATED)

August 1, 2012

Study Registration Dates

First Submitted

January 17, 2011

First Submitted That Met QC Criteria

January 18, 2011

First Posted (ESTIMATE)

January 19, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 28, 2011

Last Update Submitted That Met QC Criteria

January 27, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 10-3-088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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