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

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ClinicalTrials.gov Identifier: NCT01198704
Recruitment Status : Active, not recruiting
First Posted : September 10, 2010
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Hepatocellular Carcinoma Liver Cirrhosis Evidence of Liver Transplantation Other: 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.


Study Design

Study Type : Observational
Actual Enrollment : 372 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma
Study Start Date : January 2009
Primary Completion Date : January 2017
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Predictive factors of HCC recurrence [ Time Frame: at 2 years after Liver transplantation for HCC (modified by amendment on 17/10/2013) ]

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

Biospecimen Retention:   Samples Without DNA
Blood and serum sample (28 ml at M0, M3, M6) Tissues (one pretransplant, hepatic explant, potential resection)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198704


Locations
France
Clinique Universitaire d'Hépato-gastroentérologie
Grenoble, France, 38043
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Thomas Decaens, MD, PhD University Hospital, Grenoble
More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01198704     History of Changes
Other Study ID Numbers: AOM07237
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Fibrosis
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
Pathologic Processes
Disease Attributes