Chronic Liver DiseaseNITOutcomesNCT05312853
Evaluating the Diagnostic and Predictive Value of Non-invasive Tests (NITs) on the Progression of Chronic Liver Disease.
An observational study of Chronic Liver Disease, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Liver Disease
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jan 2024to 31 Dec 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Joern Schattenberg, Prof. Dr. contact
Germany1 site
University Medical Center of the Johannes Gutenber Univeristy
Mainz, 55131
About this study
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.
Read the 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.
- Conditions
- Chronic Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (1)
Liver-related events
Longitudinal correlation of phenotype with liver -related outcome and transplant-free survival.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start15 Jan 2024 (estimated)
- Primary completion15 Apr 2034 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim, Nordic Bioscience A/S
- Responsible party
- Principal investigator, Jörn M. Schattenberg, Johannes Gutenberg University Mainz
- Investigators
- Joern Schattenberg, Prof. Dr., Principal investigator, Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312853
- Sponsor's protocol ID
- 21-02552
- Acronym
- NITOutcomes
- Status last verified
- Dec 2023
- First submitted
- 28 Mar 2022
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Diagnostic and Predictive Value of Non-invasive Tests (NITs) on the Progression of Chronic Liver Disease.
- ClinicalTrials.gov ID
- NCT05312853
- Acronym / sponsor ID
- NITOutcomes / 21-02552
- Conditions
- Chronic Liver Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim, Nordic Bioscience A/S
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 15 Apr 2034 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Age ≥18 years
- Clinically suspected chronic liver disease based on any of:
Key exclusion criteria (6 listed)
- Refusal or inability (lack of capacity) to give informed consent.
- Age < 18 years
- Pregnancy
- An active malignancy.
- Life expectation of < 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Liver-related events
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: No. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joern Schattenberg, Prof. Dr. contact
Joern Schattenberg, Prof. Dr. principal investigator
Hepatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Liver Disease, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joern Schattenberg, Prof. Dr. (+49 (0) 6131 17 ext. 6074, joern.schattenberg@unimedizin-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.