Tumor Characteristics, Pre-transplant Treatments and Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma

March 31, 2019 updated by: Hans-Christian Pommergaard, MD, PhD, Rigshospitalet, Denmark

The Effect of Tumor Characteristics, Pre-transplant Treatments and Immunosuppression on Survival After Liver Transplantation for Hepatocellular Carcinoma - a European Registry Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

23124

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Hepatocellular carcinoma within transplantation criteria

Exclusion Criteria:

  • Disseminated disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: up to 10 year survival
up to 10 year survival

Secondary Outcome Measures

Outcome Measure
Time Frame
Hepatocellular carcinoma specific survival
Time Frame: 5 year and 10 year survival
5 year and 10 year survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Hans-Christian Pommergaard, MD, PhD, Dept. of Surgery and Transplantion, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

October 1, 2018

Study Completion (ACTUAL)

March 1, 2019

Study Registration Dates

First Submitted

December 14, 2016

First Submitted That Met QC Criteria

December 15, 2016

First Posted (ESTIMATE)

December 16, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 2, 2019

Last Update Submitted That Met QC Criteria

March 31, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • There is no unique protocol ID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The database material is available for researcher applying for data

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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