Volatile Organic Compounds (VOCs) and Liver Diseases

NCT01279356 | Unknown

• 1 other identifier: MEC 10-3-088
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Liver Diseases

Keywords

Liver diseases; Volatile organic compounds; Inflammation; Oxidative stress; non-invasive tests

Outcome Measures

Primary Outcomes (1)

• To establish the validity of VOC analysis in exhaled air to discriminate between liver diseases and non-diseased controls

  12 months

Secondary Outcomes (3)

• To compare the VOC profiles in exhaled air between various liver diseases

  12 months

• To compare the VOC analysis before, during and after therapeutic interventions in various liver diseases

  12 months

• To compare VOC profiles with systemic inflammatory and oxidative stress markers

  12 months

Study Arms (1)

Patients with liver diseases of various etiologies

* viral hepatitis * cholestatic liver diseases * auto-immune hepatitis * NAFLD * ALD * sarcoidosis of the liver

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Established diagnosis of liver diseases based on laboratory, radiological and histological characteristics
• Age between 18 and 85 years

You may not qualify if:

• Inflammatory bowel disease
• Chronic obstructive lung disease, lung cancer, asthma
• Rheumatoid arthritis

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center, Division of Gastroenterology/Hepatology

Maastricht, Limburg, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

The following biospecimens will be collected: exhaled air and plasma/serum

MeSH Terms

Conditions

Liver Diseases; Inflammation

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• A Masclee, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsten Pijls, MD

CONTACT

+31433882157; k.pijls@maastrichtuniversity.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 17, 2011
• First Posted: January 19, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 28, 2011

Record last verified: 2011-01

Locations

NL (1)