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

April 29, 2010
August 1, 2013
January 2009
March 2017   (final data collection date for primary outcome measure)
Predictive factors of HCC recurrence [ Time Frame: at 1 year after Liver transplantation for HCC ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01198704 on ClinicalTrials.gov Archive Site
  • 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 ]
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 reassessed 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
Other Name: search of factors predicting tumor recurrence
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
July 2019
March 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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01198704
AOM07237
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Thomas Decaens, MD, PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP