Clinical trial · Observational
Impacts of the α-fetoprotein (AFP) Score in Real Life for Patient Selection for Liver Transplantation (LT) for Hepatocellular Carcinoma (HCC)
NCT03156582CI-TRIAL-00058852Impact AFPcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Data collecting | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- all participants included "Milan criteria " and "AFP score"
- description
- 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)
- interventionNames
- Other: Data collecting
Primary outcomes (1)
- measure
- Number of participants whose tumoral characteristics on the liver explant were under the criteria of the AFP score
- timeFrame
- From date of registration for Liver Transplantation until the date of transplantation, assessed up to three years.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDDecaens 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
- BACKGROUNDDecaens 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
- BACKGROUNDDecaens 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
- BACKGROUNDDecaens 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
- BACKGROUNDDuvoux 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.