Evaluating the Diagnostic and Predictive Value of Non-invasive Tests (NITs) on the Progression of Chronic Liver Disease.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Liver Disease. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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 biomarkers (direct or indirect) or ultrasound-based tests, including vibration controlled transient elastography (VCTE), or a combination of both incorporated into several surrogate scores.
Primary outcome measures
- Overall survival [Time frame: 10 years]
Secondary outcome measures (1)
- Liver-related events [Time frame: 10 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
Germany · 1 center
- University Medical Center of the Johannes Gutenber Univeristy — Mainz
Identifiers
NCT: NCT05312853 · 21-02552