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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Liver Disease

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Joern Schattenberg, Prof. Dr.; Phone Number: 6074 +49 (0) 6131 17; Email: joern.schattenberg@unimedizin-mainz.de
• Study Contact Backup: Name: Belinda Schröder, MSc; Phone Number: 6075 +49 (0) 6131 17; Email: belinda.schroeder@unimedizin-mainz.de

Study Locations

• Germany
  • Mainz, Germany, 55131
    • University Medical Center of the Johannes Gutenber Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver-related events	Longitudinal correlation of phenotype with liver -related outcome and transplant-free survival.	10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Collaborators: Boehringer Ingelheim; Nordic Bioscience A/S
• Investigators: Principal Investigator: Joern Schattenberg, Prof. Dr., Hepatology

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2024
• Primary Completion (Estimated): April 15, 2034
• Study Completion (Estimated): December 31, 2034

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: 21-02552

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data and samples held by the Registry will be the property of the PI Prof. Jörn Schattenberg and the University Medical Center Mainz. Publication will be the responsibility of the PI in line with the polices established with partners in separate agreements and the requirements of the European Commission for open access publication. Scientific contributions will be duly and appropriately acknowledged in line with the 'Uniform Requirements for Articles Submitted to Biomedical Journals' produced by the Committee of Medical Journal Editors (2008).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No