The primary aim of this project is to discover new cellular (non-invasive) biomarkers for the diagnosis and monitoring of immune-mediated liver diseases. Secondly we aim to effectively differentiate AIH from DILI and NAFL from NASH.
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Immunophenotype of intrahepatic and peripheral blood leukocytes.
Secondary outcome
Histology assessment of liver biopsy
Serology
Clinical Chemistry and Hematology laboratory results
Treatment regime
Occurrence of (serious) adverse events
Background summary
Diagnosis and monitoring of immune mediated liver diseases is generally
dependent on surrogate biochemical markers which may not accurately reflect the
actual liver status. Furthermore differentiation between these diseases often
remains troublesome due to overlap in histological features. Identification of
biomarkers, immunophenotyping of the intrahepatic immunology and improving
diagnostics wil benefit
We hypothesize that the immune-mediated liver diseases AIH, DILI, NAFL and NASH
have distinct immune fingerprints that can be identified by a comprehensive
study of the cellular components of the immune system with multiparametric
single cell analysis.
Study objective
The primary aim of this project is to discover new cellular (non-invasive)
biomarkers for the diagnosis and monitoring of immune-mediated liver diseases.
Secondly we aim to effectively differentiate AIH from DILI and NAFL from NASH.
Study design
Prospective observational cohort study
Study burden and risks
The burden of patients consist of an extra tube of blood drawn during 1 or 2
blood draws that are part of standard care. In addition, leftover liver tissue
at diagnostic and follow-up liver biopsies will be used for intrahepatic
immunophenotyping. In case there is no leftover liver tissue available, we will
perform one extra biopsy to obtain liver tissue.
de Boelelaan 1118
Amsterdam 1081HZ
NL
de Boelelaan 1118
Amsterdam 1081HZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* Indication for a biopsy for the diagnosis or monitoring of; AIH, DILI, NAFL or NASH
* Eligible for liver biopsy
* * 18 years old
* Provide informed consent
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
* Contraindication for liver biopsy, determined by the clinician.
* Current infectious disease.
* Clinically relevant cardiovascular, pulmonary, or renal disease.
* Medications with possible immune-modulating effects (e.g., steroids).
* History of alcohol or drug abuse.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59115.029.16 |