Status:
NOT_YET_RECRUITING
Evaluating the Diagnostic and Predictive Value of Non-invasive Tests (NITs) on the Progression of Chronic Liver Disease.
Lead Sponsor:
Johannes Gutenberg University Mainz
Collaborating Sponsors:
Boehringer Ingelheim
Nordic Bioscience A/S
Conditions:
Chronic Liver Disease
Eligibility:
All Genders
18-99 years
Brief Summary
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 ...
Detailed Description
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 biomarker...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Clinically suspected chronic liver disease based on any of:
- Patient with historical liver biopsy providing histological evidence of any liver disease or,
- Patient undergoing liver biopsy for suspected chronic liver disease with biochemical and/or radiological findings consistent with liver disease or,
- Patient with clinical and radiological evidence of cirrhosis (in absence of an alternative aetiology)
- Patients with metabolic risk factors predisposing to CLD
Exclusion
- Refusal or inability (lack of capacity) to give informed consent.
- Age \< 18 years
- Pregnancy
- An active malignancy.
- Life expectation of \< 5 years.
- Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study.
Key Trial Info
Start Date :
January 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2034
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05312853
Start Date
January 15 2024
End Date
December 31 2034
Last Update
January 3 2024
Active Locations (1)
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1
University Medical Center of the Johannes Gutenber Univeristy
Mainz, Germany, 55131