RecruitingOBSERVATIONAL

CHronic Hepatopathies Associated With ALcohol Consumption aNd metAbolic Syndrome

This research aims to understand why some people with liver problems, either from alcohol or issues like fatty liver disease (NAFLD), go on to develop liver cancer. They want to find out what metabolic factors (how your body uses energy), immune system responses, and imaging results (like scans) are connected to liver cancer. The study will look at patients both with and without advanced liver scarring (cirrhosis) to help identify early signs of cancer development. Information will be collected during routine care, including questionnaires, blood tests, and liver scans. A liver biopsy and samples for a biobank will also be taken to help researchers learn more.

At a glance

Status

Recruiting

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Enrolment target

710

Start

06 Dec 2022

Estimated completion

01 Mar 2032

Non-Alcoholic Fatty Liver Disease Non-Alcoholic Steatohepatitis Alcohol-related Liver Disease Cirrhosis, Liver Hepatocellular Carcinoma

What is this study about?

This research study is looking into big questions about liver health. Doctors want to understand why some people with certain liver problems develop liver cancer, called hepatocellular carcinoma (HCC). This study focuses on two main types of liver disease: those caused by alcohol and those related to metabolic syndrome, which includes conditions like fatty liver disease that isn't due to alcohol.

The main goal is to identify what clues – like specific changes in your body's chemistry (metabolic factors), how your immune system behaves, and information from scans like ultrasound or MRI – might predict when someone is at risk of developing liver cancer. They are particularly interested in finding these early signs, even before severe liver scarring (cirrhosis) occurs. By studying patients both with and without cirrhosis, doctors hope to get a clearer picture of how liver cancer starts.

Taking part in this study would involve collecting information that is usually part of your routine medical care. This includes questionnaires about your diet and activity, measurements of your body, and standard blood tests that check your liver, kidney, blood sugar, and cholesterol levels. If you need a liver scan as part of your treatment, that information will also be used. A small sample of your liver (a liver biopsy) will be taken, and some blood samples will be stored in a 'biobank' for future research. This helps scientists learn more about liver diseases and cancer over time.

Key takeaways

The study investigates links between liver disease (from alcohol or unhealthy habits) and liver cancer.
It aims to find early signs and risk factors for liver cancer.
Information will be collected during your regular hospital visits and care.
A liver biopsy and blood samples will be taken and stored in a biobank for research.
Your participation helps improve understanding and future treatments for liver diseases.
You have the right to stop participating at any time without affecting your medical care.

Who may be eligible?

To join this study, you need to be at least 18 years old and be able to understand what the study involves and agree to take part in writing. You also need to be covered by French social security.

There are different groups within the study. If you have non-alcoholic fatty liver disease (NAFLD) and liver cancer, your alcohol intake must be low (less than 30g per day for men, 20g for women). If you have NAFLD but no liver cancer, your alcohol intake also needs to be low, and you must be scheduled for a routine liver biopsy because of liver issues or fatty liver shown on a scan.

If your liver disease is related to alcohol and you have liver cancer, you must have consumed more alcohol than the amounts listed above, and be scheduled for a routine liver biopsy. Similarly, if your liver disease is alcohol-related but you don't have liver cancer, you must also have consumed more alcohol than the low limits and be scheduled for a routine liver biopsy. In cases of liver cancer, you shouldn't have received specific cancer treatment for the past six months.

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?
Can you understand the study information and sign a consent form?
Do you have non-alcoholic fatty liver disease (NAFLD) or alcohol-related liver disease?
Are you scheduled for a routine liver biopsy?
If you have liver cancer, have you avoided specific cancer treatment for the last 6 months?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, your participation will involve collecting information during your routine medical care. This includes filling out questionnaires about your diet and physical activity, having body measurements taken, and undergoing standard blood tests to check various aspects of your health, including liver function, sugar levels, and inflammation.

You will also have a liver scan, if it's already part of your usual care, especially if liver cancer is suspected. A key part of the study is a liver biopsy, where a small piece of your liver is taken for examination. Additionally, some blood and tissue samples will be collected and stored in a biobank for future research. This allows scientists to study your samples over a longer period.

The time you spend actively involved in the study can be as short as one day if you sign the consent and have the biopsy on the same day. However, you have up to 8 weeks to think about it between signing the consent form and having any samples taken. The entire study itself will run for about 10 years and 2 months to include many patients and collect a lot of information.

Potential risks and benefits

Taking part in this study may offer the benefit of contributing to a better understanding of liver diseases and liver cancer, potentially leading to improved treatments for future patients. However, there are some potential risks associated with the procedures, particularly the liver biopsy, which carries a small risk of discomfort, bleeding, or other complications, similar to any routine medical procedure. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care. The researchers will discuss all potential risks and benefits with you in detail before you decide to participate.

Locations (1)

Batiment Archimed 151, route de Saint Antoine de Ginestière
Verified postcode
Nice, France· Recruiting

Common questions

What is a liver biopsy?

A liver biopsy is a procedure where a very small piece of your liver tissue is removed, usually with a needle, so doctors can look at it closely under a microscope.

What is a 'biobank'?

A biobank is like a special storage facility for biological samples, such as blood or tissue. Researchers use these stored samples to learn more about diseases over time.

What does 'cirrhosis' mean?

Cirrhosis is a serious condition where your liver is badly scarred and permanently damaged, making it difficult for the liver to work properly.

Will I get any specific treatment in this study?

No, this study mainly collects information and samples during your routine medical care. It doesn't involve any new treatments or medicines.

How long will the study last?

The entire research will last over 10 years to gather enough information. Your personal involvement could be as short as a day or up to two months for collecting samples.

How to find out more

Rodolphe Anty, MD, PhD

anty.r@chu-nice.fr 0033492035943 Official trial record

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