University Medical Center of the Johannes Gutenber Univeristy
Mainz, 55131, Germany
NCT Number: NCT05312853
Primary objective is to study the relevance of non-invasive test (NITs) in predicting disease stage (diagnostic biomarker) and outcome (predictive biomarker) in patients with suspected or established liver disease and cirrhosis.
Trial opening soon.
Get Notified18 year–99 year
All sexes
Observational
Mainz, 55131, Germany
Non-invasive tests (NITs) may complement and even reduce the need for liver biopsy in the diagnosis and follow up care of patients with chronic liver disease (CLD). NITs either include serum biomarkers (direct or indirect) or ultrasound-based tests, including vibration controlled transient elastography (VCTE), or a combination of both incorporated into several surrogate scores.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 10 years
The primary objective of this observational study is to assemble a cohort of well-characterised patients with chronic liver disease (CLD) and to collect associated clinical information, biological samples and imaging data for cross-sectional and longitudinal analyses in order to robustly validate diagnostic and predictive non-invasive tests (NITs) for the diagnosis, risk assessment (prognosis) and monitoring of patients with liver disease.
The primary outcome will be overall survival.
Time frame: 10 years
Longitudinal correlation of phenotype with liver -related outcome and transplant-free survival.
Time frame: 5 years
Contact information is provided by the study sponsor or research team.
Belinda Schröder, MSc
CONTACT
+49 (0) 6131 17 ext. 6075
Joern Schattenberg, Prof. Dr.
CONTACT
+49 (0) 6131 17 ext. 6074
Johannes Gutenberg University Mainz
Other
Acronym: NITOutcomes
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