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Volatile Organic Compounds (VOCs) and Liver Diseases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Maastricht University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01279356
First received: January 17, 2011
Last updated: January 27, 2011
Last verified: January 2011
History of Changes
  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:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the VOC profiles in exhaled air between various liver diseases [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To compare the VOC analysis before, during and after therapeutic interventions in various liver diseases [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To compare VOC profiles with systemic inflammatory and oxidative stress markers [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 17, 2011
Last Updated: January 27, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on May 19, 2013