Letzte Aktualisierung: 24.09.2025
Leberzellkarzinom (Hepatozelluläres Karzinom) [C22]
LEOPARD Training and Validation Data Collection Study
Studieninformationen
Datenerhebung für das Design und die Validierung des LEOPARD Vorhersagemodels für die Delistung von Wartelistenpatienten zur Lebertransplantation
Ziele
Primäres Prüfziel
Sekundäre Prüfziele für die Behandlungsarme:
Design
Design
Phase
Zentren
Datenerhebung
Interventionsgruppen
Verblindung
Erkrankung
Diagnose
Diagnosenbeschreibung
Mutation
Patienten
Alter
Einschlusskriterien
Ausschlusskriterien
Inclusion Criteria
• Adult [age 18;70] patients listed for:
o 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.
Therapie
Intervention
Substanz
| Prüfplancode | LEOPARD TVDCS |
|---|---|
| EudraCT | - |
| Clinicaltrials.gov | NCT06675604 |
|---|---|
| ISRCTN | - |
| DRKS | - |
Zuständige Gesamtstudie
—
Leiter der klinischen Prüfung (LKP)—
Studiengruppen/-zentrale
Kontakt Klinische Studien
CIO Aachen: Uniklinik RWTH Aachen, +49 (0) 241 80-85490
CIO Bonn: Uniklinik Bonn, +49 (0) 228 287-16036
CIO Köln: Uniklinik Köln, +49 (0) 221 478-0
CIO Düsseldorf: Uniklinik Düsseldorf, +49 (0) 211 81-04150 (Mo-Do)




