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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01198704
First received: April 29, 2010
Last updated: August 1, 2013
Last verified: July 2013
  Purpose

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 reassessed criteria for liver transplantation.


Condition Intervention
Hepatocellular Carcinoma
Liver Cirrhosis
Evidence of Liver Transplantation
Other: search of factors predicting tumor recurrence

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Predictive factors of HCC recurrence [ Time Frame: at 1 year after Liver transplantation for HCC ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Predictive factors of tumor-free recurrence [ Time Frame: at 3 years ] [ Designated as safety issue: No ]
  • Predictive factors of overall survival at 5 years [ Time Frame: at 5 years ] [ Designated as safety issue: No ]
  • Predictive factors of drop-out [ Time Frame: during the waiting time ] [ Designated as safety issue: No ]
  • Radio-pathological correlation [ Time Frame: end of the study ] [ Designated as safety issue: No ]
  • Correlation of HCC differentiation between liver biopsy and explant liver [ Time Frame: at 32 month ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood and serum sample (28 ml at M0, M3, M6) Tissues (one pretransplant, hepatic explant, potential resection)


Enrollment: 372
Study Start Date: January 2009
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other Name: search of factors predicting tumor recurrence

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient notified on the waiting list for hepatic transplant

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198704

Locations
France
Henri Mondor Hospital
Creteil, France, 94010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Thomas Decaens, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01198704     History of Changes
Other Study ID Numbers: AOM07237
Study First Received: April 29, 2010
Last Updated: August 1, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Hepatocellular carcinoma
Cirrhosis
Transplantation

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Recurrence
Liver Cirrhosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014