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

Chronic Liver Disease Clinical Trial

— NITOutcomes  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05312853
• Other study ID #: 21-02552
• Status: Not yet recruiting
• Start date: January 15, 2024
• Est. completion date: December 31, 2034

Study information

• Verified date: December 2023
• Source: Johannes Gutenberg University Mainz
• Contact: Joern Schattenberg, Prof. Dr.
• Phone: +49 (0) 6131 17
• Email: joern.schattenberg[@]unimedizin-mainz.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 liver disease and cirrhosis.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: December 31, 2034
• Est. primary completion date: April 15, 2034
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Liver Disease
• Liver Diseases

Locations

Country	Name	City	State
Germany	University Medical Center of the Johannes Gutenber Univeristy	Mainz

Sponsors (3)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz	Boehringer Ingelheim, Nordic Bioscience A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	5 years
Primary	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.	10 years
Secondary	Liver-related events	Longitudinal correlation of phenotype with liver -related outcome and transplant-free survival.	10 years