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NCT Number: NCT05312853

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center of the Johannes Gutenber Univeristy

Mainz, 55131, Germany

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: 10 years

    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.

Secondary outcomes

  1. Liver-related events

    Time frame: 10 years

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

Other outcomes

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

    Time frame: 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Belinda Schröder, MSc

CONTACT

[email protected]

+49 (0) 6131 17 ext. 6075

Joern Schattenberg, Prof. Dr.

CONTACT

[email protected]

+49 (0) 6131 17 ext. 6074

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Collaborators

  • Boehringer Ingelheim
  • Nordic Bioscience A/S

Registry information

Acronym: NITOutcomes

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Apr 6, 2022
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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