RecruitingOBSERVATIONAL

Integrated Diagnostics for Early Diagnosis of Liver Disease

This study is looking for better ways to diagnose liver disease, particularly a serious type of scarring called fibrosis. Researchers know that many people have liver problems that aren't discovered until they are very advanced, making them harder to treat. They are testing a new approach by combining information from simple blood tests, checks of single gene variations (SNPs), and analysis of gut bacteria (faecal microbiome). The goal is to see if bringing all this data together can lead to a more accurate and earlier diagnosis of liver scarring than current tests. This is an observational study, meaning researchers are gathering information without giving new treatments, to understand the disease better and improve future care for people with conditions like fatty liver disease or alcohol-related liver damage.

At a glance

Status

Recruiting

Sponsor

Manchester University NHS Foundation Trust

Enrolment target

1,200

Start

21 Oct 2020

Estimated completion

31 Mar 2027

Non-Alcoholic Fatty Liver Disease Non-alcoholic Steatohepatitis Alcoholic Liver Disease Liver Fibroses

What is this study about?

Liver disease is a big health challenge in the UK, often going unnoticed until it's quite advanced. Many people, especially in areas like the North West, might have some form of liver condition without knowing it. Sometimes, this can lead to serious scarring of the liver, called cirrhosis, which is very hard to treat once it's severe.

Currently, doctors use different tests to check for liver problems, but these tests aren't always great at finding the disease early or identifying those who are most at risk. This study wants to change that. Researchers are setting up a new system in local 'Community Liver Assessment Clinics' (CLACs) to assess people who have unusual liver blood test results or are at higher risk of liver disease. They expect to see about 750 patients each year through this new system.

As part of their normal check-ups at these clinics, patients will have various tests to help understand their liver health. The study aims to gather all this information – from routine tests, special blood tests looking at tiny genetic differences (SNPs), and checks of gut bacteria – and put it into a central database. By combining all these pieces of information and using new computer software, the researchers hope to build a much more accurate and earlier way to detect liver scarring, ultimately helping more people get the right care sooner.

Key takeaways

Aims to find better and earlier ways to diagnose liver disease, especially scarring.
Uses information from routine tests, special blood tests, and gut bacteria analysis.
Data collected from patients attending Community Liver Assessment Clinics.
No new treatments or extra procedures for participants.
Helps improve diagnosis for future patients with liver conditions.
You can stop being part of the study at any time.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older. You also need to have been referred to one of the Community Liver Assessment Clinics (CLACs) for either abnormal liver blood tests or because you're considered at high risk for liver disease. Women who are pregnant or breastfeeding, or who could become pregnant, will not be able to join. If you are a woman of childbearing age, you'll need a negative pregnancy test first.

There are also some reasons why you wouldn't be able to join. These include if you are under 18, if you already have a known liver disease that's been diagnosed or are currently very unwell. If doctors suspect you might have cancer, or if your only liver issue is high bilirubin (a yellow pigment) without other problems, you wouldn't be eligible for this study.

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.

⬜ I am 18 years old or older.
⬜ I have been referred to a Community Liver Assessment Clinic.
⬜ I am not pregnant or breastfeeding.
⬜ I don't already have a known, pre-existing serious liver disease.
⬜ I am not currently very unwell or suspected of having cancer.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it won't involve any extra appointments or special visits beyond what you would normally have for your liver assessment at the Community Liver Assessment Clinic (CLAC). All the information gathered for the study will come from tests and assessments you'd already be having as part of your routine care. This means no extra medication, no additional follow-up appointments solely for the study, and no longer total duration of assessment than otherwise planned. The researchers are simply collecting and analysing the results of your usual clinical tests in a new way to help improve diagnosis for future patients.

Potential risks and benefits

Participating in this study will not involve any direct risks to you beyond those associated with your routine clinical assessments, as no new procedures or treatments are given. The main benefit is that you will be contributing valuable information that could help researchers develop much better and earlier ways to diagnose liver disease for others in the future. You are free to withdraw from the study at any time without affecting your clinical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Manchester University NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What kind of liver diseases is this study looking at?

It's looking at common liver conditions like fatty liver disease (both alcohol-related and non-alcohol-related) and liver scarring (fibrosis).

Will I get any special treatment in this study?

No, this study is about observing and collecting information from your usual care to improve future diagnoses. You won't receive extra treatments or procedures.

How will my personal information be kept private?

The study aims to create a database, and strict procedures will be in place to ensure your information is handled securely and anonymously where appropriate.

How long will I be involved in the study?

Your involvement aligns with your normal assessment at the Community Liver Assessment Clinic. There are no additional study-specific follow-up periods.

What is a 'Community Liver Assessment Clinic'?

These are local clinics designed to check people for liver disease, particularly those with abnormal blood tests or at high risk, usually before they might need to go to a specialist hospital.

How to find out more

Varinder Athwal

varinder.athwal@manchester.ac.uk 0161 291 5354 Official trial record

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