Hepatocellular CarcinomaImpact AFPNCT03156582
Impacts of the α-fetoprotein (AFP) Score in Real Life for Patient Selection for Liver Transplantation (LT) for Hepatocellular Carcinoma (HCC)
An observational study of Hepatocellular Carcinoma, run by University Hospital, Grenoble at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Data collecting
- How many people
- 562 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2016to 1 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Data collecting
- Keywords
- liver transplantation, hepatocellular carcinoma, alpha-foetoproteins, AFP
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectingOther
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Data collecting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: Two years after liver transplantation
Rate of tumor recurrence after LT for HCC
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.
Measured: 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
Calculating the overall survival according to the last follow up of patients after LT and comparing the two arms.
Measured: 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
Calculating the progressing free survival according to the time of the eventual relapse after LT and comparing the two arms
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start1 Apr 2016
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 562 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas DECAENS, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156582
- Sponsor's protocol ID
- 38RC15.170
- Acronym
- Impact AFP
- Status last verified
- May 2022
- First submitted
- 27 Mar 2017
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15973710Decaens 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.
PubMed 16964590Decaens 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.
PubMed 17143948Decaens 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.
PubMed 21645209Duvoux 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.
PubMed 22750200Brusset 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.
PubMed 34069594
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of the α-fetoprotein (AFP) Score in Real Life for Patient Selection for Liver Transplantation (LT) for Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT03156582
- Acronym / sponsor ID
- Impact AFP / 38RC15.170
- Conditions
- Hepatocellular Carcinoma
- Keywords
- liver transplantation, hepatocellular carcinoma, alpha-foetoproteins, AFP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 562 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all participants included "Milan criteria " and "AFP score" | – | Other: Data collectingThe 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collecting | Other | all participants included "Milan criteria " and "AFP score" |
Primary outcome
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.
5 secondary outcomes
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.
Rate of early tumor recurrence after LT for HCC
Time frame: 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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Background: PubMed 15973710Decaens 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.
- Background: PubMed 16964590Decaens 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.
- Background: PubMed 17143948Decaens 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.
- Background: PubMed 21645209Decaens 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.
- Background: PubMed 22750200Duvoux 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.
- Derived from this study: PubMed 34069594Brusset 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas DECAENS principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03156582, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.