Volatile Organic Compounds (VOCs) and Liver Diseases

NCT ID: NCT01279356

Last Updated: 2011-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with liver diseases of various etiologies

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Maastricht University Medical Center

Principal Investigators

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A Masclee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

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Maastricht University Medical Center, Division of Gastroenterology/Hepatology

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Kirsten Pijls, MD

Role: CONTACT

+31433882157

Facility Contacts

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Kirsten Pijls, MD

Role: primary

+31433882157

Other Identifiers

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MEC 10-3-088

Identifier Type: -

Identifier Source: org_study_id

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