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NCT04363424
Alcohol Biomarker Study
trial in Alcoholic Cirrhosis in 191 participants. Status unknown.
1 July 2021
Quick facts
| Lead sponsor | Maastricht University Medical Center |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 191 |
| Start date | 1 April 2020 |
| Primary completion | 1 July 2021 |
| Estimated completion | 1 August 2021 |
| Sites | 1 location across Netherlands |
Conditions studied
- Alcoholic Cirrhosis — all drugs for Alcoholic Cirrhosis →
Sponsor
Maastricht University Medical Center
Who can join
18 and older, any sex, with Alcoholic Cirrhosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Phosphatidylethanol and ethyl glucuronide to categorize alcohol consumption in alcohol-related cirrhosis.
Vanlerberghe BTK, Dumitrascu C, den Eede NV, Neels H, et al · · 2025 · cited 5× · PMID 40677698 · DOI 10.1016/j.jhepr.2025.101433
Verify or expand the search:
- PubMed search for NCT04363424
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other recruiting trials for Alcoholic Cirrhosis
Currently open trials in the same condition.
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- NCT04689152 — Clinical Trial to Evaluate the Efficacy and Safety of Cellgram-LC Administration in Patients With Alcoholic Cirrhosis · Phase 3 · recruiting
- NCT04250259 — SAMe Trial for Patients With Alcoholic Cirrhosis · Phase 2 · recruiting
Other Maastricht University Medical Center trials
Trials by the same sponsor.
- NCT04603261 — Time to Excretion of Contrast, a Maastricht Prospective Observational Study · withdrawn
- NCT04598516 — Maastricht Investigation of Renal Function in Absence of- and Post- Contrast in Patients With eGFR LEss Than 30 · withdrawn
- NCT04597892 — Efficacy of Point-Of-Care Creatinine Assays in Patients With eGFR <30 Receiving Intravascular Contrast · withdrawn
- NCT07287358 — Optimal Cerebral Perfusion Pressure Guided Therapy: Assessment of Target Effectiveness - II · NA · not yet recruiting
- NCT07501780 — Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04363424 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Maastricht University Medical Center
- Last refreshed: 27 April 2020
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