Alcohol Biomarker Study

NCT04363424 | Unknown

• 2 other identifiers: NL71593.068.19METC 19-080
• Study Type: observational
• Target: 191
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alcoholic Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (2)

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.

Eligibility Criteria

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

Study Population

Patients with alcoholic liver disease will be included from the in- outpatient clinic of the Maastricht University Medical Center.

You may qualify if:

• Age \> 18 years old.
• For the clinical application group: patients with ALD who deny moderate or excessive alcohol use in the previous 3 months.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Universiteit Antwerpen: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 40677698 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis, Alcoholic

Condition Hierarchy (Ancestors)

Liver Cirrhosis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Central Study Contacts

Jef Verbeek, MD, PhD

CONTACT

0032/16.34.47.75; jef.verbeek@uzleuven.be

Ad Masclee, MD, PhD

CONTACT

0031/433.87.50.21; a.masclee@mumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 27, 2020
• Study Start: April 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: August 1, 2021
• Last Updated: April 27, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)