Impacts of the α-fetoprotein (AFP) Score in Real Life for Patient Selection for Liver Transplantation (LT) for Hepatocellular Carcinoma (HCC) (Impact AFP)

May 31, 2022 updated by: University Hospital, Grenoble
This is a French multicentric retrospective study on intention-to-treat comparing results of LT for HCC before and after the use of the AFP score. The investigators hypothesis is a better respect of the Biomedicine Agency (the French national transplantation agency) criteria since the general application of this score in March 2013. The aim of this study is to determine if the tumoral characteristics at the time of LT are improved and if it modified the patients'outcome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Liver transplantation is a widely accepted treatment for HCC as it would eliminate the tumour and cure the underlying liver disease. But the success of liver transplantation depends on the tumour load; patients with extensive disease have very poor outcomes, whereas most patients with small tumours can be curred. This had to be taken into account in the context of worldwide organ shortage.

That is why in 1996 Mazzaferro et al. have reported Milan criteria limiting access to liver transplantation for patients with a single tumor ≤ 5 cm or ≤ 3 tumors ≤ 3 cm without tumor invasion or metastasis.

However, in France, these criteria were not respected in about 30% of cases, because they were considered too restrictive and unadapted, with good overall results. This led to the possibility of new criteria definition. Because the value of alpha-foeto-protein was known as a good predictor of tumor aggressivity, a new score emerged in 2012, integrating blocking α-fetoprotein thresholds while allowing an increased number and size of tumors. After validation of this score, the Biomedicine Agency decided to use this α-fetoprotein score, to make the selection of patients allowed to be transplanted since March 2013.

In this multicentric retrospective comparative study The investigators first want to assess if this new score based on imaging is also respected at the explant analysis. Our secondary outcomes are to compare the amount of dropped out patients because of this score, the rate of tumoral relapse, the overall survival and the disease free survival.

The investigators aim at collecting the data of 562 patients registered for Liver Transplantation for Hepatocellular Carcinoma between 2011/03/01 and 2014/03/01 in 5 centres: Paul Brousse (Paris), Montpellier, Lille, Lyon and Grenoble.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
562

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • University Hospital, Grenoble Alpes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients registred for Liver Transplantation because of an Hepatocellular Carcinoma between 2011/03/01 and 2014/03/01 in 5 French centres: Paul Brousse (Paris), Montpellier, Lille, Lyon and Grenoble.

Description

Inclusion Criteria:

  • patients registered for liver transplantation because of Hepatocellular carcinoma between 2011/03/01 and 2014/03/01 in 5 french hospital : Paul Brousse (Paris), Montpellier, Lille Lyon and Grenoble

Exclusion Criteria:

  • Patients with a MELD score superior to 20 (because this rate give them access to liver transplantation sooner than the other patients).
  • Patients of Domino's grafts
  • patients with non hepatocellular tumors on the explanted liver

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
all participants included "Milan criteria " and "AFP score"

The first arm is made of liver recipients or dropped off list patients at the time of the Milan criteria (fixed until 2013/06/01 for transplanted patients because mandatory three months reevaluation of patients obliged the various teams to respect the criteria at this time, but until 2013/03/01 for dropped off patients because we did not want to count dropped of because of the AFP score in this arm).

The second arm is made of liver recipients or dropped off list patients at the time of the AFP score (fixed after 2013/06/01)for transplanted patients and after 2013/03/01 for dropped off patients)
Other: Data collecting

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants whose tumoral characteristics on the liver explant were under the criteria of the AFP score
Time Frame: From date of registration for Liver Transplantation until the date of transplantation, assessed up to three years.
For participants undergoing transplantation, the investigators calculated their AFP score at the time of LT, according to the last value of alphafoetoprotein rate, the number and the size of tumors on the explant. They compared the number of patients whose tumoral characteristics on the liver explant were under the criteria of the AFP score in the two arms.
From date of registration for Liver Transplantation until the date of transplantation, assessed up to three years.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of patients dropped off list of LT for HCC
Time Frame: From date of registration on the list until the date of exclusion, assessed up to three years.
Determining if a patient has been excluded by his Transplantation team because of a tumor beyond the Agence de Biomedecine's criteria and comparing the two arms.
From date of registration on the list until the date of exclusion, assessed up to three years.
Rate of early tumor recurrence after LT for HCC
Time Frame: Two years after liver transplantation
Determining in the follow up of patients if they present a liver or extra-hepatic recurrence of HCC at 2 years after LT and comparing the two arms.
Two years after liver transplantation
Rate of tumor recurrence after LT for HCC
Time Frame: From the date of transplantation until the first documented recurrence, assessed through study completion, an average of three years.
Determining in the follow up of patients after LT if they present a liver or extra-hepatic recurrence of HCC and comparing the two arms.
From the date of transplantation until the first documented recurrence, assessed through study completion, an average of three years.
Overall survival after LT for HCC
Time Frame: From the date of transplantation until the date of death or the date of the last consultation, assessed through study completion, an average of three years
Calculating the overall survival according to the last follow up of patients after LT and comparing the two arms.
From the date of transplantation until the date of death or the date of the last consultation, assessed through study completion, an average of three years
Progression free survival after LT for HCC
Time Frame: From the date of transplantation until the date of first documented recurrence or the date of the last consultation if no recurrence occurs, assessed through study completion, an average of three years.
Calculating the progressing free survival according to the time of the eventual relapse after LT and comparing the two arms
From the date of transplantation until the date of first documented recurrence or the date of the last consultation if no recurrence occurs, assessed through study completion, an average of three years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas DECAENS, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 38RC15.170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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