NCT03595345

Brief Summary

The present study has been developed with multiple aims: 1) to refine available models for liver transplantation which would be able to cover the fate of HCC candidates from an ITT point of view; 2) to develop such an approach on cohorts coming from both Eastern and Western countries; 3) to maintain simplicity of use; 4) to provide individual prognostication taking into account different causes of death, through a competing-risk model; 5) to provide an external validation on cohorts coming from both Eastern and Western countries. All these aims converge at providing a comprehensive and useful assessment suitable for both candidates selection and allocation priority.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2018

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

1.8 years

First QC Date

July 11, 2018

Last Update Submit

October 26, 2018

Conditions

Liver CancerDropout, PatientRecurrence

Keywords

delistingtumor-specific deathMilan Criteria

Outcome Measures

Primary Outcomes (1)

  • Tumour-specific death

    Death for recurrence or other HCC-related causes

    5 years after transplant

Secondary Outcomes (1)

  • Drop-out

    1 year after waiting list inscription

Study Arms (3)

Training set

2200 HCC cases from East and West centres enlisted for LT and then delisted or transplanted

Procedure: Liver transplantation

West validation set

630 HCC cases from a Western centre enlisted for LT and then delisted or transplanted

Procedure: Liver transplantation

East validation set

300 HCC cases from a Eastern centre enlisted for LT and then delisted or transplanted

Procedure: Liver transplantation

Interventions

Liver transplantationPROCEDURE

Liver transplantation

East validation setTraining setWest validation set

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participating centers for the creation of the training set cohort were: Brussels (Belgium; n=355), New York Columbia University/Weill Cornell Medical Center (USA; n=353), Innsbruck (Austria; n=330), New Delhi (India; n=270), Rome Sapienza University (Italy; n=265), Kyoto (Japan; n=230), Taiwan (Republic of China; n=200), Mainz (Germany; n=176), Kyushu (Japan; n=161), and Hangzhou Shulan Health Hospital/First Affiliated Hospital (Popular Republic of China; n=94). For the testing/external cohort, two additional centres participated to the study, namely the Western center from Padua (Italy; n=630) and the Easter center from Hong Kong (n=330) applying the same inclusion/exclusion criteria as for the training cohort.

You may qualify if:

  • All the adult ((≥18 years) patients enlisted for liver transplant with the radiological/histological diagnosis of hepatocellular cancer during the period 01/01/2000-31/03/2017

You may not qualify if:

  • Mixed hepatocellular-cholangiocellular
  • Cholangiocellular cancer misdiagnosed as HCC
  • Post-LT incidental HCC.
  • Patients enlisted before 01/01/2000

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCL

Brussels, Belgium

Location

MeSH Terms

Conditions

Liver NeoplasmsPatient DropoutsRecurrence

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsDigestive System Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator and Data manager of the EurHeCaLT Study Group

Study Record Dates

First Submitted

July 11, 2018

First Posted

July 23, 2018

Study Start

December 15, 2016

Primary Completion

October 15, 2018

Study Completion

October 15, 2018

Last Updated

October 29, 2018

Record last verified: 2018-10

Locations

BE(1)