Ignite Creation Date:
2024-05-06 @ 10:03 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03156582
Status:
COMPLETED
Last Update Posted:
2022-06-01
First Post:
2017-03-27
Brief Title:
Impacts of the α-fetoprotein AFP Score in Real Life for Patient Selection for Liver Transplantation LT for Hepatocellular Carcinoma HCC
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Impacts of the α-fetoprotein AFP Score in Real Life for Patient Selection for Liver Transplantation LT for Hepatocellular Carcinoma HCC
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Impact AFP
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 patientsoutcome
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 20110301 and 20140301 in 5 centres Paul Brousse Paris Montpellier Lille Lyon and Grenoble
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 20110301 and 20140301 in 5 centres Paul Brousse Paris Montpellier Lille Lyon and Grenoble
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None