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

NCT03156582 | Completed

• 1 other identifier: 38RC15.170
• Study Type: observational
• Target: 562
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Keywords

liver transplantation, hepatocellular carcinoma, alpha-foetoproteins, AFP

Outcome Measures

Primary Outcomes (1)

• Number of participants whose tumoral characteristics on the liver explant were under the criteria of the AFP score

  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 Outcomes (5)

• Rate of patients dropped off list of LT for HCC

  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

  Two years after liver transplantation

• Rate of tumor recurrence after LT for HCC

  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

  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

  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.

Study Arms (1)

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

Interventions

Data collecting OTHER

all participants included "Milan criteria " and "AFP score"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital, Grenoble Alpes

Grenoble, 38043, France

Location

Related Publications (6)

• Decaens T, Roudot-Thoraval F, Bresson-Hadni S, Meyer C, Gugenheim J, Durand F, Bernard PH, Boillot O, Boudjema K, Calmus Y, Hardwigsen J, Ducerf C, Pageaux GP, Dharancy S, Chazouilleres O, Dhumeaux D, Cherqui D, Duvoux C. Impact of pretransplantation transarterial chemoembolization on survival and recurrence after liver transplantation for hepatocellular carcinoma. Liver Transpl. 2005 Jul;11(7):767-775. doi: 10.1002/lt.20418.

  PMID: 15973710 BACKGROUND

• Decaens T, Roudot-Thoraval F, Hadni-Bresson S, Meyer C, Gugenheim J, Durand F, Bernard PH, Boillot O, Sulpice L, Calmus Y, Hardwigsen J, Ducerf C, Pageaux GP, Dharancy S, Chazouilleres O, Cherqui D, Duvoux C. Impact of UCSF criteria according to pre- and post-OLT tumor features: analysis of 479 patients listed for HCC with a short waiting time. Liver Transpl. 2006 Dec;12(12):1761-9. doi: 10.1002/lt.20884.

  PMID: 16964590 BACKGROUND

• Decaens T, Roudot-Thoraval F, Bresson-Hadni S, Meyer C, Gugenheim J, Durand F, Bernard PH, Boillot O, Compagnon P, Calmus Y, Hardwigsen J, Ducerf C, Pageaux GP, Dharancy S, Chazouilleres O, Cherqui D, Duvoux C. Role of immunosuppression and tumor differentiation in predicting recurrence after liver transplantation for hepatocellular carcinoma: a multicenter study of 412 patients. World J Gastroenterol. 2006 Dec 7;12(45):7319-25. doi: 10.3748/wjg.v12.i45.7319.

  PMID: 17143948 BACKGROUND

• Decaens T, Roudot-Thoraval F, Badran H, Wolf P, Durand F, Adam R, Boillot O, Vanlemmens C, Gugenheim J, Dharancy S, Bernard PH, Boudjema K, Calmus Y, Hardwigsen J, Ducerf C, Pageaux GP, Hilleret MN, Chazouilleres O, Cherqui D, Mallat A, Duvoux C. Impact of tumour differentiation to select patients before liver transplantation for hepatocellular carcinoma. Liver Int. 2011 Jul;31(6):792-801. doi: 10.1111/j.1478-3231.2010.02425.x. Epub 2011 Mar 31.

  PMID: 21645209 BACKGROUND

• Duvoux C, Roudot-Thoraval F, Decaens T, Pessione F, Badran H, Piardi T, Francoz C, Compagnon P, Vanlemmens C, Dumortier J, Dharancy S, Gugenheim J, Bernard PH, Adam R, Radenne S, Muscari F, Conti F, Hardwigsen J, Pageaux GP, Chazouilleres O, Salame E, Hilleret MN, Lebray P, Abergel A, Debette-Gratien M, Kluger MD, Mallat A, Azoulay D, Cherqui D; Liver Transplantation French Study Group. Liver transplantation for hepatocellular carcinoma: a model including alpha-fetoprotein improves the performance of Milan criteria. Gastroenterology. 2012 Oct;143(4):986-94.e3; quiz e14-5. doi: 10.1053/j.gastro.2012.05.052. Epub 2012 Jun 29.

  PMID: 22750200 BACKGROUND

• Brusset B, Dumortier J, Cherqui D, Pageaux GP, Boleslawski E, Chapron L, Quesada JL, Radenne S, Samuel D, Navarro F, Dharancy S, Decaens T. Liver Transplantation for Hepatocellular Carcinoma: A Real-Life Comparison of Milan Criteria and AFP Model. Cancers (Basel). 2021 May 19;13(10):2480. doi: 10.3390/cancers13102480.

  PMID: 34069594 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Officials

• Thomas DECAENS

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: May 17, 2017
• Study Start: April 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)