LEOPARD Training and Validation Data Collection Study

In plain English

What this trial is testing

Condition(s) listed: Decompensated Liver Cirrhosis, Primary Biliary Cholangitis and Primary Sclerosing Cholangitis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.

Who can join

• Ages 18 to 70
• Any sex

Some of the main requirements, copied from the record:

• Adult \[age 18;70\] patients listed for:
• decompensated cirrhosis as primary diagnosis, irrespective of liver disease etiology (subset 1) OR
• other chronic end-stage liver diseases requiring LT, to be listed under a MELD-based allocation system (examples: primary biliary cholangitis, primary sclerosing cholangitis etc…) (subset 2) OR
• HCC* as primary diagnosis, whatever the etiology of the underlying liver disease with or without underlying cirrhosis (subset 3). (HCC diagnosed on Barcelona/EASL criteria or histologically proven. HCC meeting or not Milan criteria, as per…
• Patients registered on national waiting lists under the MELD offering schemes, regardless of extra MELD points and MELD exceptions are affected or not.
• Patient (or trusted person, family member or close relation, if the patient is unable to be informed) who has been informed and did not express opposition to data collection

Plus 1 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 4500 participants are expected to take part.
• The study has 3 groups.
• Start date: 2025-02-04.
• Main results expected around 2028-03 (estimate from the record).
• 53 study sites listed (53 marked recruiting) in Austria, Belgium, France, Germany and Italy and 2 more countries.

Groups in this study

• Subset 1
• Subset 2
• Subset 3

Main thing being measured

• Clinical primary endpoint considered as the event of interest to be predicted will be a composite of number of participants with mortality or drop out for being too sick on transplantation waiting… (3 months after listing in subsets 1 & 2 ; 12 months after listing in subset3)

In the researchers’ words

Intro: The present clinical research protocol is part of the LEOPARD European project (Grant n° 101080964 Horizon Europe) which aims to design and validate new predictive models of mortality among liver transplantation (LT) candidates. MELD based-liver graft allocation systems have become increasingly inaccurate over the last decade to predict mortality/dropout of liver transplantation (LT) candidates on the…

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.