Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
191 participants
OBSERVATIONAL
2020-04-01
2021-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
cACLD in Patients With Alcohol Use Disorder in the Hospital Detoxification Unit
NCT06838468
Use of Novel Plasma and Urinary Biomarkers to Predict the Development of Hepatorenal Syndrome in Cirrhotic Patients
NCT02434445
Healthcare Utilization in Liver Cirrhosis Patients, a Multicenter Retrospective Cohort Study
NCT06150482
Integrated Approaches for Identifying Molecular Targets in Alcoholic Hepatitis
NCT02075918
Complex Exploratory Study of Alcohol-Associated Hepatitis
NCT06358196
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Validation cohort
Patients with alcoholic cirrhosis with reliable self-reported alcohol use.
No interventions assigned to this group
Clinical application cohort
Patients with alcoholic cirrhosis who deny moderate or excessive alcohol use in the previous 3 months.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universitaire Ziekenhuizen KU Leuven
OTHER
Universiteit Antwerpen
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
METC 19-080
Identifier Type: OTHER
Identifier Source: secondary_id
NL71593.068.19
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.