LEOPARD Training and Validation Data Collection Study

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Nov 4, 2024

Keywords

ClinConnect Summary

The LEOPARD Training and Validation Data Collection Study is a research project aimed at improving how doctors predict which patients on the waiting list for liver transplants are at the highest risk of not receiving a transplant in time. This study is essential because current methods haven't been very accurate, with some countries seeing a much higher percentage of patients dropping off the waiting list than others. By using advanced technology and collecting data from thousands of patients across Europe, the goal is to create better tools to help ensure that patients who need a transplant the most receive it more fairly and promptly.

To be eligible to participate, patients must be adults aged 18 to 70 who are on the waiting list for a liver transplant due to severe liver disease, which could include conditions like decompensated cirrhosis or liver cancer. Participants will be part of a large group where their health data will be collected and analyzed to help develop these predictive models. This study is currently recruiting and involves multiple healthcare centers across seven countries. If you or a loved one meets the criteria, you could play a vital role in improving liver transplant processes for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * 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 center practice.)
• • 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
• • (\*Of note, enrolment of patients with T1 tumors (1 single tumor \< 2 cm diameter) not amenable to loco-regional therapies because of decompensation, and prioritized under the MELD system, will be allowed in Subset 1.)
• Exclusion Criteria:
• • Tumor vascular invasion (portal or hepatic veins) evidenced by imaging at pre transplantation work-up, including portal vein thrombosis stage 1
• • Extra-hepatic metastasis of HCC, as assessed by sectional imaging, functional imaging (18 FDG PET CT/MRI) or histologically proven
• • Patients who are under safeguard of justice or tutorship or curatorship
• • Patient on AME (state medical aid)
• • Participation to LEOPARD PVC 1 study of WP2