Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma (HCC) (EFAPRE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01198704|
Recruitment Status : Active, not recruiting
First Posted : September 10, 2010
Last Update Posted : November 6, 2017
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|
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|
|Actual Enrollment :||372 participants|
|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|
Patients notified on the national waiting list for hepatic transplant
Other: search of factors predicting tumor recurrence
Morphological, chronological, anatomy-pathological and molecular search
- Predictive factors of HCC recurrence [ Time Frame: at 2 years after Liver transplantation for HCC (modified by amendment on 17/10/2013) ]
- Predictive factors of tumor-free recurrence [ Time Frame: at 3 years ]
- Predictive factors of overall survival at 5 years [ Time Frame: at 5 years ]
- Predictive factors of drop-out [ Time Frame: during the waiting time ]
- Radio-pathological correlation [ Time Frame: end of the study ]
- Correlation of HCC differentiation between liver biopsy and explant liver [ Time Frame: at 32 month ]
Biospecimen Retention: Samples Without DNA
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
|Clinique Universitaire d'Hépato-gastroentérologie|
|Grenoble, France, 38043|
|Principal Investigator:||Thomas Decaens, MD, PhD||University Hospital, Grenoble|