Not yet recruitingOBSERVATIONAL

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

This study aims to discover how useful new, simpler tests are for people with ongoing liver problems. These tests, called non-invasive tests (NITs), are designed to check the health of your liver without needing a biopsy. The main goals are to see if these NITs can accurately tell how advanced your liver disease is at the moment and predict how it might change over time. If successful, these easier tests could help doctors monitor liver disease more effectively and potentially reduce the need for more uncomfortable procedures like liver biopsies. This research could lead to better and more comfortable ways to manage chronic liver disease for patients.

At a glance

Status

Not yet recruiting

Sponsor

Johannes Gutenberg University Mainz

Enrolment target

250

Start

15 Jan 2024

Estimated completion

31 Dec 2034

Chronic Liver Disease

What is this study about?

When someone has long-lasting liver problems, doctors need to understand how well the liver is working and how the disease is changing. Traditionally, a liver biopsy, which involves taking a small piece of liver tissue, has been used for this. However, biopsies can be uncomfortable and carry some risks.

This study is looking into newer, simpler tests that don't involve a biopsy. These are called non-invasive tests (NITs) because they don't require going inside the body. They include things like blood tests, which check certain chemicals in your blood, and special ultrasound scans, like one called VCTE, which measures how stiff your liver is. A stiffer liver can be a sign of more advanced scarring.

The researchers want to see if these easy tests can accurately show how serious your liver disease is now and if they can help predict what might happen in the future. By doing this, they hope to find better, more comfortable ways to diagnose and monitor chronic liver disease, potentially meaning fewer people need a liver biopsy.

Key takeaways

This study evaluates new, easier tests for liver disease.
It aims to predict how liver disease progresses without biopsies.
Participants must be 18 or over with suspected or confirmed liver disease.
Tests involve blood samples and special ultrasound scans.
The goal is to find better, less invasive ways to monitor liver health.
You can withdraw from the study at any time.

Who may be eligible?

You might be able to take part in this study if you are 18 years old or older and have, or are suspected to have, long-lasting liver disease. This could be because you've had a liver biopsy before that showed liver problems, or you're about to have one. It also includes people who have signs of advanced scarring in their liver (cirrhosis) or those with risk factors for liver disease, such as certain metabolic conditions.

However, some people cannot join. You can't take part if you are under 18 or are pregnant. If you have active cancer, a very short life expectancy (less than 5 years), or are unable to understand and agree to take part, you would also not be eligible. The study team will make the final decision on whether it's right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have, or are you suspected of having, long-lasting liver disease?
Are you pregnant? (If yes, you can't join)
Do you have a current active cancer? (If yes, you can't join)
Are you able to understand information and agree to take part?

Answer every question to see your result.

What does participation involve?

The detailed steps for taking part aren't fully described, but you would likely undergo several 'non-invasive tests.' These could include blood tests to check various markers in your system and ultrasound scans, like VCTE, which uses sound waves to check liver stiffness. You would also have regular check-ups to monitor your liver health over time. The study aims to see how these tests compare to your actual liver condition and how your disease progresses. The total duration of your participation would be confirmed by the study team.

Potential risks and benefits

Taking part in this study could potentially help advance our understanding of chronic liver disease, leading to better diagnostic and monitoring tools in the future, which might mean fewer people need invasive procedures like biopsies. However, like any study, there are potential small risks, mainly associated with having blood tests or scans. You would also need to attend appointments, which takes time. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it won't affect your medical care.

Locations (1)

University Medical Center of the Johannes Gutenber Univeristy
Verified postcode
Mainz, Germany

Common questions

What is 'chronic liver disease'?

It means you have a long-lasting condition affecting your liver.

What are 'non-invasive tests'?

These are tests that don't involve needles or surgery, like blood tests or special scans, to check your liver.

Will I still need a liver biopsy if I join?

The study aims to see if these new tests can reduce the need for biopsies, but your doctor will advise on what's best for you.

How long will I be in the study?

The exact length isn't specified, but the study team will provide all the details about the duration and number of visits.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect your medical care.

How to find out more

Joern Schattenberg, Prof. Dr.

joern.schattenberg@unimedizin-mainz.de +49 (0) 6131 17 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.