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

NCT05312853 | Not Yet Recruiting DMC

• 1 other identifier: 21-02552
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Liver Disease

Outcome Measures

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.

  10 years

Secondary Outcomes (1)

• Liver-related events

  10 years

Other Outcomes (1)

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

  5 years

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Refusal or inability (lack of capacity) to give informed consent.
• Age \< 18 years
• Pregnancy
• An active malignancy.
• Life expectation of \< 5 years.

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead
• Boehringer Ingelheim: collaborator
• Nordic Bioscience A/S: collaborator

Study Sites (1)

University Medical Center of the Johannes Gutenber Univeristy

Mainz, 55131, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

1. 3 x 5mls into EDTA (purple) Vacutainer blood tubes - used for plasma collection for subsequent biomarker or metabolomic/proteomic/miRNA/cell-free DNA analyses and cellular DNA extraction. 2. 4 x 5mls (or 2 x 10mls) into GOLD top SST Vacutainer tubes (serum) - used for serum collection for subsequent biomarker or metabolomic/proteomic/miRNA/cell-free DNA analyses. \[Note: RED top Vacutainer tubes (serum) may be substituted if GOLD tubes are not available locally\]. 3. 1 x 5mls into PAX tube for RNA preservation - for peripheral blood RNA extraction.

Study Officials

• Joern Schattenberg, Prof. Dr.

  Hepatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joern Schattenberg, Prof. Dr.

CONTACT

+49 (0) 6131 17; joern.schattenberg@unimedizin-mainz.de

Belinda Schröder, MSc

CONTACT

+49 (0) 6131 17; belinda.schroeder@unimedizin-mainz.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 6, 2022
• Study Start: January 15, 2024
• Primary Completion (Estimated): April 15, 2034
• Study Completion (Estimated): December 31, 2034
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)