NCT02995096

Brief Summary

Recurrence after liver transplantation for hepatocellular carcinoma (HCC) represents an important cause of mortality for this surgical population. In addition to tumor characteristics, It has been suggested that pre-treatment and sirolimus-based immunosuppression may affect recurrence and survival. With data from the European Liver Transplant Registry (ELTR) database, the aim of this study is to investigate the impact of tumor characteristics, pre-transplant treatment and immunosuppression regimens on survival after liver transplantation for HCC.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
23,124

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

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

January 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

April 2, 2019

Status Verified

March 1, 2019

Enrollment Period

2.8 years

First QC Date

December 14, 2016

Last Update Submit

March 31, 2019

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    up to 10 year survival

Secondary Outcomes (1)

  • Hepatocellular carcinoma specific survival

    5 year and 10 year survival

Interventions

Pre-treatmentPROCEDURE

Non-transplantation pre-treatments prior to transplantation (e.g. radiofrequency ablation, transcatheter arterial chemoembolization)

Sirolimus based immunosuppressionDRUG

Immunosuppression regimens containing Sirolimus

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving liver transplantation for hepatocellular carcinoma in European centers reporting to the ELTR database.

You may qualify if:

  • Hepatocellular carcinoma within transplantation criteria

You may not qualify if:

  • Disseminated disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Treatment Expectations

Intervention Hierarchy (Ancestors)

Treatment OutcomePrognosisDiagnosisOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Evaluation MechanismsHealth Care Quality, Access, and Evaluation

Study Officials

  • Hans-Christian Pommergaard, MD, PhD

    Dept. of Surgery and Transplantion, Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

December 14, 2016

First Posted

December 16, 2016

Study Start

January 1, 2016

Primary Completion

October 1, 2018

Study Completion

March 1, 2019

Last Updated

April 2, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

The database material is available for researcher applying for data