LEOPARD Prospective Validation Cohort 1

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

Keywords

ClinConnect Summary

The LEOPARD Prospective Validation Cohort 1 clinical trial is studying new ways to predict which patients with liver diseases are at the highest risk of needing a liver transplant and may not survive while waiting for one. The goal is to improve existing systems that currently do not always accurately predict patient outcomes. This study will involve up to 600 patients across 30 hospitals in five European countries, focusing on individuals with conditions like decompensated liver cirrhosis, primary biliary cholangitis, primary sclerosing cholangitis, or liver cancer.

To be eligible for this trial, participants must be adults aged 18 to 70 who are already listed for a liver transplant due to one of the specified liver diseases. They should also be registered on national waiting lists for liver transplants. Participants will undergo regular check-ups and contribute to research by providing medical data and samples. It's important to note that certain individuals, such as those with specific types of cancer spread or those who are pregnant, cannot participate. This trial aims to make liver transplantation more fair and effective for patients in need.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Adult \[age 18;70\] patients listed for:
• • decompensated cirrhosis as primary diagnosis, irrespective of liver disease etiology (subset1) OR
• • other end-stage liver diseases requiring LT, listed under MELD offering schemes (subset 2), including notably but not exclusively cholestatic diseases, primary biliary cholangitis, primary sclerosing cholangitis (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 are affected or not.
• • Patient (or trusted person, family member or close relation, if the patient is unable to express consent) who has been informed and signed the informed consent.
• • Patient affiliated with a health insurance scheme (beneficiary or entitled party).
• Exclusion Criteria:
• • Tumor vascular invasion (portal or hepatic veins) evidenced by imaging on pre transplantation work-up, including PVT stage 1
• • Extra-hepatic metastasis of HCC, as assessed by sectional imaging, functional imaging (18 FDG PET CT/MRI) or histologically proven
• • Women who are pregnant or nursing
• • Patients who are under safeguard of justice or tutorship or curatorship
• • Patient on AME (state medical aid)
• • Participation in another trial including other studies proposed as part of the European LEOPARD project (cohort associated to WP1 \& WP5 ("LEOPARD TVDCS") or being in the exclusion period following previous interventional research involving the human person, if applicable