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

NCT ID: NCT01198704

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

372 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2020-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma Liver Cirrhosis Evidence of Liver Transplantation

Keywords

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Hepatocellular carcinoma Cirrhosis Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HCC patients

Patients notified on the national waiting list for hepatic transplant

search of factors predicting tumor recurrence

Intervention Type OTHER

Morphological, chronological, anatomy-pathological and molecular search

Interventions

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search of factors predicting tumor recurrence

Morphological, chronological, anatomy-pathological and molecular search

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Decaens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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Clinique Universitaire d'Hépato-gastroentérologie

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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AOM07237

Identifier Type: -

Identifier Source: org_study_id