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

Johannes Gutenberg University (JGU)

Status: Not yet enrolling

Conditions: Chronic Liver Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05312853

21-02552

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years

2. Clinically suspected chronic liver disease based on any of:

   1. Patient with historical liver biopsy providing histological evidence of any liver disease or,
   2. Patient undergoing liver biopsy for suspected chronic liver disease with biochemical and/or radiological findings consistent with liver disease or,
   3. Patient with clinical and radiological evidence of cirrhosis (in absence of an alternative aetiology)
   4. Patients with metabolic risk factors predisposing to CLD

Exclusion criteria

1. Refusal or inability (lack of capacity) to give informed consent.
2. Age < 18 years
3. Pregnancy
4. An active malignancy.
5. Life expectation of < 5 years.
6. Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study.