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

NCT01198704 | Completed

• 1 other identifier: AOM07237
• Study Type: observational
• Target: 372
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Liver Cirrhosis; Evidence of Liver Transplantation

Keywords

Hepatocellular carcinoma; Cirrhosis; Transplantation

Outcome Measures

Primary Outcomes (1)

• Predictive factors of HCC recurrence

  at 2 years after Liver transplantation for HCC (modified by amendment on 17/10/2013)

Secondary Outcomes (5)

• Predictive factors of tumor-free recurrence

  at 3 years

• Predictive factors of overall survival at 5 years

  at 5 years

• Predictive factors of drop-out

  during the waiting time

• Radio-pathological correlation

  end of the study

• Correlation of HCC differentiation between liver biopsy and explant liver

  at 32 month

Study Arms (1)

HCC patients

Patients notified on the national waiting list for hepatic transplant

Other: search of factors predicting tumor recurrence

Interventions

search of factors predicting tumor recurrence OTHER

Morphological, chronological, anatomy-pathological and molecular search

HCC patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient notified on the waiting list for hepatic transplant

You may qualify if:

• 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

You may not qualify if:

• Salvage transplantation
• Transplantation contra-indication
• Evaluation for Liver transplantation older than 1 month
• Incidental HCC

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Clinique Universitaire d'Hépato-gastroentérologie

Grenoble, 38043, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Cirrhosis; Fibrosis

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Decaens, MD, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: September 10, 2010
• Study Start: January 1, 2009
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2020
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

FR (1)