Status:
UNKNOWN
Alcohol Biomarker Study
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Universitaire Ziekenhuizen KU Leuven
Universiteit Antwerpen
Conditions:
Alcoholic Cirrhosis
Eligibility:
All Genders
18+ years
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 indicati...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
191 Patients enrolled
Trial Details
Trial ID
NCT04363424
Start Date
April 1 2020
End Date
August 1 2021
Last Update
April 27 2020
Active Locations (1)
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1
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229 HX