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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01198704
First Posted: September 10, 2010
Last Update Posted: November 6, 2017
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.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
April 29, 2010
September 10, 2010
November 6, 2017
January 2009
January 2017   (Final data collection date for primary outcome measure)
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 HCC recurrence [ Time Frame: at 1 year after Liver transplantation for HCC ]
Complete list of historical versions of study NCT01198704 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma (HCC)
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Blood and serum sample (28 ml at M0, M3, M6) Tissues (one pretransplant, hepatic explant, potential resection)
Non-Probability Sample
Patient notified on the waiting list for hepatic transplant
  • Hepatocellular Carcinoma
  • Liver Cirrhosis
  • Evidence of Liver Transplantation
Other: search of factors predicting tumor recurrence
Morphological, chronological, anatomy-pathological and molecular search
HCC patients
Patients notified on the national waiting list for hepatic transplant
Intervention: Other: search of factors predicting tumor recurrence
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
372
January 2020
January 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01198704
AOM07237
No
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Thomas Decaens, MD, PhD University Hospital, Grenoble
Assistance Publique - Hôpitaux de Paris
November 2017