Liver DiseasesNCT01279356
Volatile Organic Compounds (VOCs) and Liver Diseases
An observational study of Liver Diseases, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Liver Diseases
- How many people
- 160 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2011to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include patients with various liver diseases visiting the outpatient clinic.
Who may be able to join
- Established diagnosis of liver diseases based on laboratory, radiological and histological characteristics
- Age between 18 and 85 years
Who cannot join
- Inflammatory bowel disease
- Chronic obstructive lung disease, lung cancer, asthma
- Rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center, Division of Gastroenterology/Hepatology
Maastricht, Limburg
Kirsten Pijls, MD, +31433882157, k.pijls@maastrichtuniversity.nl
About this study
Official title: 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.
- Conditions
- Liver Diseases
- Keywords
- Liver diseases, Volatile organic compounds, Inflammation, Oxidative stress, non-invasive tests
- Medical subject headings
- Liver Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with liver diseases of various etiologies | * viral hepatitis * cholestatic liver diseases * auto-immune hepatitis * NAFLD * ALD * sarcoidosis of the liver |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the validity of VOC analysis in exhaled air to discriminate between liver diseases and non-diseased controls
Measured: 12 months
Secondary outcomes (3)
To compare the VOC profiles in exhaled air between various liver diseases
Measured: 12 months
To compare the VOC analysis before, during and after therapeutic interventions in various liver diseases
Measured: 12 months
To compare VOC profiles with systemic inflammatory and oxidative stress markers
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- A Masclee, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279356
- Sponsor's protocol ID
- MEC 10-3-088
- Status last verified
- Jan 2011
- First submitted
- 17 Jan 2011
- Last updated
- 28 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Volatile Organic Compounds in Exhaled Air as a Non-invasive Biomarker for Liver Diseases
- ClinicalTrials.gov ID
- NCT01279356
- Acronym / sponsor ID
- MEC 10-3-088
- Conditions
- Liver Diseases
- Keywords
- Liver diseases, Volatile organic compounds, Inflammation, Oxidative stress, non-invasive tests
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with liver diseases of various etiologies | – | –* viral hepatitis * cholestatic liver diseases * auto-immune hepatitis * NAFLD * ALD * sarcoidosis of the liver |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients with various liver diseases visiting the outpatient clinic.
Key inclusion criteria (2 listed)
- Established diagnosis of liver diseases based on laboratory, radiological and histological characteristics
- Age between 18 and 85 years
Key exclusion criteria (3 listed)
- Inflammatory bowel disease
- Chronic obstructive lung disease, lung cancer, asthma
- Rheumatoid arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To establish the validity of VOC analysis in exhaled air to discriminate between liver diseases and non-diseased controls
Time frame: 12 months
3 secondary outcomes
To compare the VOC profiles in exhaled air between various liver diseases
Time frame: 12 months
To compare the VOC analysis before, during and after therapeutic interventions in various liver diseases
Time frame: 12 months
To compare VOC profiles with systemic inflammatory and oxidative stress markers
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A Masclee, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kirsten Pijls, MD (+31433882157, k.pijls@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish the validity of VOC analysis in exhaled air to discriminate between liver diseases and non-diseased controls (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2011.