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Alcohol Biomarker Study

NCT04363424 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 191

Last updated 2020-04-27

No results posted yet for this study

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

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • Universiteit Antwerpen

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2021-07-01
Completion
2021-08-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04363424 on ClinicalTrials.gov