RecruitingNAINTERVENTIONAL

SCREaning of Advanced Liver Fibrosis Using Non-Invasive Tests in General Population

This study is checking if a simple blood test called FIB4, which is often calculated automatically by labs, can help find advanced liver scarring (fibrosis) earlier. Liver scarring can lead to serious conditions like cirrhosis or liver cancer, which can be life-threatening if not found early. Doctors usually recommend targeted screening for people with known liver risk factors, but some labs now check FIB4 for everyone. This study wants to see if this widespread testing, followed by specialist checks for those with high FIB4 results, is a good way to find and treat liver problems sooner in adults aged 18 to 70 and improve their health outcomes.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Angers

Enrolment target

502

Start

20 Oct 2023

Estimated completion

01 Mar 2027

Screening Advanced Liver Fibrosis

What is this study about?

Many serious liver problems, like scarring (fibrosis), cirrhosis, and liver cancer, can develop slowly over time without people knowing. These conditions often aren't found until they are quite advanced, which makes them harder to treat and can sadly shorten people's lives. Finding these problems earlier is really important for getting the right care and improving health.

There's a simple blood test called FIB4 that can give doctors an idea of how much scarring might be in the liver. It's calculated from other routine blood tests you might have. While doctors usually recommend this test for people who already have known risk factors for liver disease, some laboratories now automatically calculate FIB4 for everyone having certain blood tests.

This study wants to find out if this widespread, automatic FIB4 testing is a good idea. Specifically, it's looking at whether people with a certain high FIB4 result (above 2.67) should automatically have more specialised liver checks. The aim is to see if this approach can help identify advanced liver scarring earlier in more people, allowing them to get specialist treatment sooner and potentially prevent serious complications.

Key takeaways

This study explores a new way to check for serious liver scarring.
It uses a common blood test called FIB4, calculated routinely by labs.
The goal is to find advanced liver problems earlier in more people.
Early detection could lead to better and sooner treatment.
Participation might involve a specialist liver check-up.

Who may be eligible?

To join this study, you need to be an adult aged between 18 and 70 years old. You would also need to have recently had a blood test at one of the medical labs taking part in the study, where your FIB4 score was calculated and found to be above 2.67. Importantly, your blood test results for AST, ALT, and platelets should also fall within certain ranges to make sure your FIB4 result is reliable for the study.

You cannot join if you are already seeing a specialist for a long-term liver problem. Also, pregnant or breastfeeding women cannot take part. If you have any difficulty understanding French, are in certain legal situations, or cannot freely agree to participate, you won't be able to join. You must also be part of a social security system.

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 between 18 and 70 years old?
Did you recently have a blood test at a participating lab?
Was your FIB4 score calculated as above 2.67?
Are you NOT currently seeing a specialist for a long-term liver problem?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

The study aims to use information from your existing blood tests. If your FIB4 result, automatically calculated by the lab, is above a certain level (2.67), you might be asked to take part. If you agree, you will need to sign a consent form. The study will involve a specialised check-up for your liver to see if there's advanced scarring. The total duration of your involvement isn't specified, but it focuses on that initial screening and follow-up evaluation.

Potential risks and benefits

Taking part could help identify advanced liver scarring early, allowing you to get specialist care sooner. This could potentially prevent serious complications like cirrhosis or liver cancer. There are no specific risks mentioned for participating beyond what is involved in a standard specialist liver evaluation. You are always free to change your mind and withdraw from the study at any time without it affecting your medical care.

Locations (6)

Chu Angers
Verified postcode
Angers, France· Not yet recruiting
Chu Bordeaux
Verified postcode
Angers, France· Not yet recruiting
Chu Grenoble Alpes
Verified postcode
Grenoble, France· Recruiting
Centre Hospitalier de Lens
Verified postcode
Lens, France· Recruiting
Hopital Saint Joseph
Verified postcode
Marseille, France· Not yet recruiting
Chu Nancy
Verified postcode
Nancy, France· Recruiting

Common questions

What is advanced liver fibrosis?

Advanced liver fibrosis means there is significant scarring in your liver, which can lead to serious problems like cirrhosis (severe scarring) and liver cancer if not found and managed early.

What is a FIB4 test?

FIB4 is a simple calculation based on routine blood test results (AST, ALT, and platelets) that can help predict the amount of scarring in your liver without needing more invasive tests.

Why is early screening important?

Early screening helps find liver problems when they are less severe, allowing doctors to provide treatment or advice sooner. This can help prevent the condition from getting worse and improve your overall health.

Will I need to change my medication?

This study focuses on screening and diagnosis. Any decisions about medication would be made by your doctor based on your individual health needs, not directly as part of participating in the study.

Who is running this study?

The study involves looking at screening methods to help healthcare professionals identify liver issues more effectively, specifically related to how labs automatically calculate a blood test called FIB4 for a wider group of people.

How to find out more

Clémence CANIVET, MD, PHD

clemence.canivet@chu-angers.fr (0)241353142 Official trial record

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