Alcoholic CirrhosisNCT04363424
Alcohol Biomarker Study
An observational study of Alcoholic Cirrhosis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Objective: To validate ethyl glucuronide in scalp hair, fingernail and urine as a biomarker for alcohol use in patients with alcoholic cirrhosis. Background: Alcoholic cirrhosis is a leading indication for liver transplantation in abstinent patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholic Cirrhosis
- How many people
- 191 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2020to 1 Aug 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with alcoholic liver disease will be included from the in- outpatient clinic of the Maastricht University Medical Center.
Who may be able to join
- Diagnosis of alcoholic liver cirrhosis: consensus of the medical team based on (1) the patient history alcohol use (2) the exclusion of other causes of liver disease by blood analysis and (3) if available, liver histology findings.
- Age > 18 years old.
- For the validation cohort: reliable self-reported alcohol use. The reliability of this self-report will be based on (1) an interview by the researcher at study inclusion, (2) an interview by the physician at inclusion.
- For the clinical application group: patients with ALD who deny moderate or excessive alcohol use in the previous 3 months.
Who cannot join
- Other liver disease than alcoholic liver cirrhosis: viral hepatitis, auto-immune liver disease, hereditary hemochromatosis, Wilson's disease and cholestatic liver diseases (primary biliary cholangitis, primary sclerosing cholangitis) and α1-antitrypsine deficiency.
- For the validation group: unreliable self-reported alcohol use. Patients will be excluded in case of any doubt or inconsistency concerning the self-reported alcohol use.
- Pregnancy and breastfeeding.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX
Jef Verbeek, MD, PhD, 0032/16.34.47.75, jef.verbeek@uzleuven.be
About this study
Official title: Phenotypical and Pathophysiological Characterization of Patients With Alcohol-related Liver Disease
Objective: To validate ethyl glucuronide in scalp hair, fingernail and urine as a biomarker for alcohol use in patients with alcoholic cirrhosis.
Background: Alcoholic cirrhosis is a leading indication for liver transplantation in abstinent patients. However, the assessment of alcohol use remains a daily diagnostic challenge. Ethyl glucuronide (EtG) is the most promising biomarker for the detection of alcohol use. EtG can be both a short-term (urinary EtG) and long-term biomarker (scalp hair and nail EtG). Although EtG is synthetized in the hepatocyte, the validation of these biomarkers and their proposed cut-off values is not present or scarce in patients with cirrhosis, impeding their widespread clinical use.
Read more
Therefore, the investigators will assess the diagnostic accuracy of EtG in scalp hair, fingernail and urine in a cohort of patients with cirrhosis. In addition, the investigators will apply a new mass spectrometry imaging (MSI) method to visualize the distribution of EtG in scalp hair, allowing a visual chronological assessment of alcohol intake based on a single hair strand.
Methods: Blood, proximal scalp hair, fingernail samples and urine will be collected from patients with alcoholic cirrhosis at the Maastricht University Medical Center. Alcohol intake in the previous 3 months will be questioned using the Timeline Followback method. The diagnostic accuracy of hair EtG (analyzed with matrix-assisted laser desorption/ionization-MSI and routine gas chromatography-tandem mass spectrometry (GC-MS/MS)), fingernail and urinary EtG (both GC-MS/MS) for moderate and excessive alcohol use will be assessed in a validation cohort. Secondly, the investigators will assess the diagnostic potential of these EtG biomarkers in a clinical application group of patients with alcoholic cirrhosis undergoing screening for liver transplantation.
Anticipated results: The combination of different EtG biomarkers allows accurate assessment of abstinence and alcohol use in patients with alcoholic cirrhosis and therefore can be implemented in the daily care of liver patients.
- Conditions
- Alcoholic Cirrhosis
- Medical subject headings
- Liver Cirrhosis, Alcoholic
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 |
|---|---|---|
| Validation cohort | Patients with alcoholic cirrhosis with reliable self-reported alcohol use. | |
| Clinical application cohort | Patients with alcoholic cirrhosis who deny moderate or excessive alcohol use in the previous 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of non-invasive alcohol biomarkers (urinary, hair and fingernail ethyl glucuronide) based on self-reported alcohol intake.
Urine, hair and fingernail samples will be collected at a single point in time. The diagnostic accuray (sensitivity, specificity, positive and negative predictive value) of urine, hair and fingernail ethyl glucuronide will be based on self reported alcohol intake assessed by the alcohol timeline followback method.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start1 Apr 2020
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcoholic CirrhosisStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 191 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Universiteit Antwerpen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363424
- Sponsor's protocol ID
- NL71593.068.19
- Other IDs
- METC 19-080
- Status last verified
- Apr 2020
- First submitted
- 21 Apr 2020
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vanlerberghe BTK, Dumitrascu C, den Eede NV, Neels H, van Malenstein H, Gevers TJG, Kramer M, Van Melkebeke L, Masclee AAM, de Boer D, van der Merwe S, Nevens F, van Nuijs ALN, Verbeek J. Phosphatidylethanol and ethyl glucuronide to categorize alcohol consumption in alcohol-related cirrhosis. JHEP Rep. 2025 Apr 24;7(8):101433. doi: 10.1016/j.jhepr.2025.101433. eCollection 2025 Aug.
PubMed 40677698
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypical and Pathophysiological Characterization of Patients With Alcohol-related Liver Disease
- ClinicalTrials.gov ID
- NCT04363424
- Acronym / sponsor ID
- NL71593.068.19
- Conditions
- Alcoholic Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 191 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Universiteit Antwerpen
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 27 Apr 2020 (actual)
- 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.
Objective: To validate ethyl glucuronide in scalp hair, fingernail and urine as a biomarker for alcohol use in patients with alcoholic cirrhosis.
Background: Alcoholic cirrhosis is a leading indication for liver transplantation in abstinent patients. However, the assessment of alcohol use remains a daily diagnostic challenge. Ethyl glucuronide (EtG) is the most promising biomarker for the detection of alcohol use. EtG can be both a short-term (urinary EtG) and long-term biomarker (scalp hair and nail EtG). Although EtG is synthetized in the hepatocyte, the validation of these biomarkers and their proposed cut-off values is not present or scarce in patients with cirrhosis, impeding their widespread clinical use.
Therefore, the investigators will assess the diagnostic accuracy of EtG in scalp hair, fingernail and urine in a cohort of patients with cirrhosis. In addition, the investigators will apply a new mass spectrometry imaging (MSI) method to visualize the distribution of EtG in scalp hair, allowing a visual chronological assessment of alcohol intake based on a single hair strand.
Methods: Blood, proximal scalp hair, fingernail samples and urine will be collected from patients with alcoholic cirrhosis at the Maastricht University Medical Center. Alcohol intake in the previous 3 months will be questioned using the Timeline Followback method. The diagnostic accuracy of hair EtG (analyzed with matrix-assisted laser desorption/ionization-MSI and routine gas chromatography-tandem mass spectrometry (GC-MS/MS)), fingernail and urinary EtG (both GC-MS/MS) for moderate and excessive alcohol use will be assessed in a validation cohort. Secondly, the investigators will assess the diagnostic potential of these EtG biomarkers in a clinical application group of patients with alcoholic cirrhosis undergoing screening for liver transplantation.
Anticipated results: The combination of different EtG biomarkers allows accurate assessment of abstinence and alcohol use in patients with alcoholic cirrhosis and therefore can be implemented in the daily care of liver patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Validation cohort | – | –Patients with alcoholic cirrhosis with reliable self-reported alcohol use. |
| Clinical application cohort | – | –Patients with alcoholic cirrhosis who deny moderate or excessive alcohol use in the previous 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with alcoholic liver disease will be included from the in- outpatient clinic of the Maastricht University Medical Center.
Key inclusion criteria (4 listed)
- Diagnosis of alcoholic liver cirrhosis: consensus of the medical team based on (1) the patient history alcohol use (2) the exclusion of other causes of liver disease by blood analysis and (3) if available, liver histology findings.
- Age > 18 years old.
- For the validation cohort: reliable self-reported alcohol use. The reliability of this self-report will be based on (1) an interview by the researcher at study inclusion, (2) an interview by the physician at inclusion.
- For the clinical application group: patients with ALD who deny moderate or excessive alcohol use in the previous 3 months.
Key exclusion criteria (3 listed)
- Other liver disease than alcoholic liver cirrhosis: viral hepatitis, auto-immune liver disease, hereditary hemochromatosis, Wilson's disease and cholestatic liver diseases (primary biliary cholangitis, primary sclerosing cholangitis) and α1-antitrypsine deficiency.
- For the validation group: unreliable self-reported alcohol use. Patients will be excluded in case of any doubt or inconsistency concerning the self-reported alcohol use.
- Pregnancy and breastfeeding.
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
Diagnostic accuracy of non-invasive alcohol biomarkers (urinary, hair and fingernail ethyl glucuronide) based on self-reported alcohol intake.
Time frame: 3 months
Urine, hair and fingernail samples will be collected at a single point in time. The diagnostic accuray (sensitivity, specificity, positive and negative predictive value) of urine, hair and fingernail ethyl glucuronide will be based on self reported alcohol intake assessed by the alcohol timeline followback method.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Derived from this study: PubMed 40677698Vanlerberghe BTK, Dumitrascu C, den Eede NV, Neels H, van Malenstein H, Gevers TJG, Kramer M, Van Melkebeke L, Masclee AAM, de Boer D, van der Merwe S, Nevens F, van Nuijs ALN, Verbeek J. Phosphatidylethanol and ethyl glucuronide to categorize alcohol consumption in alcohol-related cirrhosis. JHEP Rep. 2025 Apr 24;7(8):101433. doi: 10.1016/j.jhepr.2025.101433. eCollection 2025 Aug.
- Individual participant dataSharing planned: No
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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.
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 Alcoholic Cirrhosis, 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 4 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 27 Apr 2020. 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 Jef Verbeek, MD, PhD (0032/16.34.47.75, jef.verbeek@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of non-invasive alcohol biomarkers (urinary, hair and fingernail ethyl glucuronide) based on self-reported alcohol intake. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04363424, which also lists 1 linked publication.
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 27 Apr 2020; AzTrials last refreshed its copy on 28 Oct 2026.