Evaluating the Diagnostic and Predictive Value of Non-invasive Tests (NITs) on the Progression of Chronic Liver Disease.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorJohannes Gutenberg University Mainz

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

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)

Disqualifiers

Refusal or inability (lack of capacity) to give informed consent.

Age < 18 years

Pregnancy

An active malignancy.

Trial population

The study population will be patients (aged ≥18 years) with risk factors for chronic liver disease recruited at the I. Department of Medicine of the University Medical Center Mainz in Germany.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Overall survival

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

Secondary outcomes

1

Liver-related events

Longitudinal correlation of phenotype with liver -related outcome and transplant-free survival.

Time frame
10 years

Other outcomes

1

Impact of liver disease on Quality of Life and Symptom-burden

* Study of symptom burden in patients with CLD (Quality of Life). * Study the underlying pathogenic processes contributing to disease progression in CLD

Time frame
5 years

Sponsors and contacts

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Johannes Gutenberg University Mainz

Lead sponsor

Boehringer Ingelheim

Collaborator

Nordic Bioscience A/S

Collaborator

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