Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma (HCC) (EFAPRE)

November 19, 2020 updated by: Assistance Publique - Hôpitaux de Paris

Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma

Results of liver transplantation, the best theoretical treatment for HCC, are limited by tumor recurrence. In order to limit this risk Milan criteria was proposed in 1996. However, these criteria are to restrictive and approximately 40% of patients denied by Milan criteria may be cured by liver transplantation.

The purpose of this study was thus to prospectively evaluate factors predicting tumor recurrence after liver transplantation for HCC and then to reassess criteria for liver transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, the investigators studied the predictive value of imaging techniques such as CT, MRI, PET scan, of serological markers and molecular markers assessed before liver transplantation at listing.

The investigators also evaluated the predictive value of tumor growing during the waiting time (imaging and serological).

Finally, the investigators compared pre-LT data and explanted liver analysis to evaluate accuracy of liver biopsy and of imaging.

Study Type

Observational

Enrollment (Actual)

372

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • Clinique Universitaire d'Hépato-Gastroentérologie

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient notified on the waiting list for hepatic transplant

Description

Inclusion Criteria:

  • Liver cirrhosis
  • Hepatocellular carcinoma diagnosed by AASLD criteria or liver biopsy
  • Listing for Liver transplantation for HCC fulfilling or not Milan criteria
  • No extra-hepatic spread
  • No vascular involvement

Exclusion Criteria:

  • Salvage transplantation
  • Transplantation contra-indication
  • Evaluation for Liver transplantation older than 1 month
  • Incidental HCC

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HCC patients
Patients notified on the national waiting list for hepatic transplant
Other: search of factors predicting tumor recurrence
Morphological, chronological, anatomy-pathological and molecular search

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Predictive factors of HCC recurrence
Time Frame: at 2 years after Liver transplantation for HCC (modified by amendment on 17/10/2013)
at 2 years after Liver transplantation for HCC (modified by amendment on 17/10/2013)

Secondary Outcome Measures

Outcome Measure
Time Frame
Predictive factors of tumor-free recurrence
Time Frame: at 3 years
at 3 years
Predictive factors of overall survival at 5 years
Time Frame: at 5 years
at 5 years
Predictive factors of drop-out
Time Frame: during the waiting time
during the waiting time
Radio-pathological correlation
Time Frame: end of the study
end of the study
Correlation of HCC differentiation between liver biopsy and explant liver
Time Frame: at 32 month
at 32 month

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Thomas Decaens, MD, PhD, University Hospital, Grenoble

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

January 1, 2009

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

April 29, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (Estimate)

September 10, 2010

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOM07237

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.

Clinical Trials on Liver Cirrhosis

Clinical Trials on search of factors predicting tumor recurrence

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe