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Phenotypical and Pathophysiological Characterization of Patients with Alcohol-related Liver Disease.

Phenotypical and Pathophysiological Characterization of Patients with Alcohol-related Liver Disease. - Alcohol Biomarker Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49648
Enrollment
191
Registered
2020-03-03
Start date
2021-06-09
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

alcohol use disorder alcoholic liver disease

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - diagnosis of ALD - age>18 years old - 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. - clinical application group: patients with ALD who deny moderate or excessive alcohol intake in the last three months

Exclusion criteria

Exclusion criteria: - Other liver disease than ALD: more concrete: viral hepatitis, auto-immune liver disease, hereditary hemochromatosis, Wilson's disease, cholestatic liver diseases (primary biliary cholangitis, primary sclerosing cholangitis) en *1- antitrypsine deficiency. - unreliable self-reported alcohol use - Pregnancy and breastfeeding - Incompetent to understand and/or sign the informed consent - Unwilling to provide biosamples

Design outcomes

Primary

MeasureTime frame
To identify, develop and validate non-invasive biomarkers in blood, scalp hair, fingernails and urine for the assessment of alcohol use in patients with ALD with and without cirrhosis.

Secondary

MeasureTime frame
Identify the effect of liver cirrhosis and alcoholic liver disease on the diagnostic accuracy of non-invasive biomarkers for the assessment of alcohol use in patients with ALD. Identify, develop and validate future non-invasive biomarkers for the assessment of alcohol use in patients with ALD. To obtain body samples from patients with ALD for translational studies on the pathophysiology and treatment of ALD, with a focus on the gut-liver axis, this includes blood, exhaled air, urine, stools and optionally, when endoscopy is part of standard care, also intestinal biopsy samples

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)