RecruitingOBSERVATIONAL

LEOPARD Training and Validation Data Collection Study

This study, called LEOPARD, is gathering health information from thousands of patients with serious liver conditions across Europe. The main goal is to create new and improved ways to predict which patients on the liver transplant waiting list are at the highest risk of becoming very ill or even dying before they can get a new liver. Current methods don't always work as well as they should, and there are differences in how patients are prioritised in different countries. By using advanced computer programs (AI or artificial intelligence), researchers hope to develop better tools. These tools will help doctors decide more accurately who needs a transplant most urgently, ensuring that those patients at highest risk get the lifesaving treatment they need sooner and more fairly across Europe.

At a glance

Status

Recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

4,500

Start

04 Feb 2025

Estimated completion

04 Feb 2029

Decompensated Liver Cirrhosis Primary Biliary Cholangitis Primary Sclerosing Cholangitis Hepato-cellular Carcinoma

What is this study about?

Imagine you have a serious liver condition and are waiting for a liver transplant. Doctors currently use a system to decide who is most urgent, but this system isn't perfect. It can be hard to predict who might get much sicker while waiting, and access to transplants can vary a lot between different countries.

That's where the LEOPARD project comes in. It's a big European study aiming to make this process fairer and more accurate. Researchers are collecting detailed health information from many patients with severe liver diseases like decompensated cirrhosis (where the liver has stopped working well), primary biliary cholangitis, primary sclerosing cholangitis, and liver cancer (hepatocellular carcinoma).

The goal is to use this information to build new, smarter prediction tools, powered by artificial intelligence. These tools will help doctors identify patients who are at the highest risk of getting worse or even dying while on the waiting list. By doing this, the study hopes to ensure that the patients who need a new liver most desperately receive one in time, leading to better outcomes and more equal access to transplants across Europe.

Key takeaways

This study aims to make liver transplant waiting lists fairer and more effective.
It uses medical data from patients with serious liver diseases across Europe.
The goal is to develop new tools using AI to better predict who needs a transplant urgently.
You won't have any extra tests or treatments if you join; it's mainly about sharing your health information.
Your participation helps improve outcomes for future liver transplant patients.
You can withdraw your consent for your data to be used at any time.

Who may be eligible?

To be part of this study, you need to be an adult, between 18 and 70 years old, and currently on the waiting list for a liver transplant. This includes people with severe liver conditions where the liver isn't working properly (decompensated cirrhosis), other serious long-term liver diseases like primary biliary cholangitis or primary sclerosing cholangitis, or a type of liver cancer called hepatocellular carcinoma.

It's important that you are listed for transplant under the MELD scoring system, which is used to prioritise patients. You (or a family member, if you're unable) must be told about the study and not object to your health information being used.

However, you wouldn't be able to join if your liver cancer has spread to your blood vessels or other parts of your body. Also, if you are under certain legal protections or receiving specific government medical aid, or participating in another part of the LEOPARD project, you wouldn't be eligible.

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?
Are you currently on the waiting list for a liver transplant?
Do you have decompensated cirrhosis, another serious chronic liver disease, or hepatocellular carcinoma?
Your liver cancer has not spread to your blood vessels or other parts of your body?
Have you been informed about the study and don't object to your health data being used?

Answer every question to see your result.

What does participation involve?

This study involves collecting your routine healthcare information. This means researchers will gather data from your medical records that doctors already collect as part of your normal care while you are on the liver transplant waiting list. You won't be asked to undergo any extra tests, visits to the clinic, or take any new medications specifically for this study. The researchers will simply follow your progress over time, using the information already being collected by your medical team.

Potential risks and benefits

The main benefit of taking part is contributing to a major effort to improve liver transplant care for future patients. By helping researchers develop better ways to identify those most in need, this study could lead to fairer and more effective transplant decisions. There are no direct medical benefits to you from participating. Since this study only involves collecting existing health information, there are no physical risks. The main risk involves privacy; however, strict measures will be in place to protect your data. You have the right to withdraw your permission for your data to be used at any time without affecting your medical care.

Locations (22)

Universitätsklinik für Allgemeinchirurgie, Klinische Abteilung für Transplantation
Verified postcode
Vienna, Austria· Recruiting
Department of Gastroenterology and Hepatology Universitair Ziekenhuis Gent
Verified postcode
Ghent, Belgium· Not yet recruiting
CHU Jean Minjoz Besançon, Department of Hepatology
Verified postcode
Besançon, France· Recruiting
CHU Trousseau Tours, Department of Hepatology
Verified postcode
Chambray-lès-Tours, France· Recruiting
CHU Beaujon, Department of Hepatology
Verified postcode
Clichy, France· Recruiting
Hospital Henri Mondor, Department of Hepatology
Verified postcode
Créteil, France· Recruiting
CHU Dijon, Department of Hepatology
Verified postcode
Dijon, France· Recruiting
CHRU Huriez Lille, Department of Hepatology
Verified postcode
Lille, France· Recruiting
CHU Lyon Croix Rousse, Department of Hepatology
Verified postcode
Lyon, France· Not yet recruiting
CHU La Timone AP-HM, Department of Hepatology
Verified postcode
Marseille, France· Not yet recruiting
CHRU Montpellier Saint Eloi, Department of Hepatology
Verified postcode
Montpellier, France· Recruiting
CHU L'Archet Nice, Department of Hepatology
Verified postcode
Nice, France· Recruiting

Common questions

What is the main goal of the LEOPARD study?

The main goal is to create better ways to predict which liver transplant patients are at highest risk while waiting, to ensure they get a new liver more fairly and quickly.

Will I have to take any new medicines or have extra tests?

No, this study only collects information from your existing medical records. You won't have any extra tests or medications.

Who is funding this research?

This project is part of the European project 'Horizon Europe', which is funded by the European Commission.

What is 'AI' and why is it used?

AI stands for Artificial Intelligence, which are computer programs that can learn from data. It's used here to build smarter prediction tools based on all the patient information collected.

If I join, does it mean I'll get a transplant faster?

No, taking part in this data collection study won't directly affect your place on the transplant waiting list or when you receive a transplant. It's for future patient benefits.

How to find out more

Christophe DUVOUX, MD-PHD

christophe.duvoux@aphp.fr 01 49 81 23 25 Official trial record

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