Hepatocellular CarcinomaEFAPRENCT01198704
Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma (HCC)
An observational study of Hepatocellular Carcinoma and Liver Cirrhosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Results of liver transplantation, the best theoretical treatment for HCC, are limited by tumor recurrence. In order to limit this risk Milan criteria was proposed in 1996. However, these criteria are to restrictive and approximately 40% of patients denied by Milan criteria may be cured by liver transplantation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cirrhosis, Evidence of Liver Transplantation
- What is being tested?
- search of factors predicting tumor recurrence
- How many people
- 372 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Jan 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient notified on the waiting list for hepatic transplant
Who may be able to join
- Liver cirrhosis
- Hepatocellular carcinoma diagnosed by AASLD criteria or liver biopsy
- Listing for Liver transplantation for HCC fulfilling or not Milan criteria
- No extra-hepatic spread
- No vascular involvement
Who cannot join
- Salvage transplantation
- Transplantation contra-indication
- Evaluation for Liver transplantation older than 1 month
- Incidental HCC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma
Results of liver transplantation, the best theoretical treatment for HCC, are limited by tumor recurrence. In order to limit this risk Milan criteria was proposed in 1996. However, these criteria are to restrictive and approximately 40% of patients denied by Milan criteria may be cured by liver transplantation.
The purpose of this study was thus to prospectively evaluate factors predicting tumor recurrence after liver transplantation for HCC and then to reassess criteria for liver transplantation.
Read the detailed description
In this study, the investigators studied the predictive value of imaging techniques such as CT, MRI, PET scan, of serological markers and molecular markers assessed before liver transplantation at listing.
The investigators also evaluated the predictive value of tumor growing during the waiting time (imaging and serological).
Finally, the investigators compared pre-LT data and explanted liver analysis to evaluate accuracy of liver biopsy and of imaging.
- Being tested
- search of factors predicting tumor recurrence
- Keywords
- Hepatocellular carcinoma, Cirrhosis, Transplantation
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Cirrhosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
search of factors predicting tumor recurrenceOther
Morphological, chronological, anatomy-pathological and molecular search
| Study group | Role | What they receive |
|---|---|---|
| HCC patients | Patients notified on the national waiting list for hepatic transplant Receives: Other: search of factors predicting tumor recurrence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive factors of HCC recurrence
Measured: at 2 years after Liver transplantation for HCC (modified by amendment on 17/10/2013)
Secondary outcomes (5)
Predictive factors of tumor-free recurrence
Measured: at 3 years
Predictive factors of overall survival at 5 years
Measured: at 5 years
Predictive factors of drop-out
Measured: during the waiting time
Radio-pathological correlation
Measured: end of the study
Correlation of HCC differentiation between liver biopsy and explant liver
Measured: at 32 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startJan 2009
- Primary completionJan 2017
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prospective
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Decaens, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198704
- Sponsor's protocol ID
- AOM07237
- Acronym
- EFAPRE
- Status last verified
- Nov 2020
- First submitted
- 29 Apr 2010
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01198704
- Acronym / sponsor ID
- EFAPRE / AOM07237
- Keywords
- Hepatocellular carcinoma, Cirrhosis, Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 10 Sep 2010 (estimated)
- 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.
Results of liver transplantation, the best theoretical treatment for HCC, are limited by tumor recurrence. In order to limit this risk Milan criteria was proposed in 1996. However, these criteria are to restrictive and approximately 40% of patients denied by Milan criteria may be cured by liver transplantation.
The purpose of this study was thus to prospectively evaluate factors predicting tumor recurrence after liver transplantation for HCC and then to reassess criteria for liver transplantation.
Detailed description
In this study, the investigators studied the predictive value of imaging techniques such as CT, MRI, PET scan, of serological markers and molecular markers assessed before liver transplantation at listing.
The investigators also evaluated the predictive value of tumor growing during the waiting time (imaging and serological).
Finally, the investigators compared pre-LT data and explanted liver analysis to evaluate accuracy of liver biopsy and of imaging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCC patients | – | Other: search of factors predicting tumor recurrencePatients notified on the national waiting list for hepatic transplant |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient notified on the waiting list for hepatic transplant
Key inclusion criteria (5 listed)
- Liver cirrhosis
- Hepatocellular carcinoma diagnosed by AASLD criteria or liver biopsy
- Listing for Liver transplantation for HCC fulfilling or not Milan criteria
- No extra-hepatic spread
- No vascular involvement
Key exclusion criteria (4 listed)
- Salvage transplantation
- Transplantation contra-indication
- Evaluation for Liver transplantation older than 1 month
- Incidental HCC
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 |
|---|---|---|
| search of factors predicting tumor recurrenceMorphological, chronological, anatomy-pathological and molecular search | Other | HCC patients |
Primary outcome
Predictive factors of HCC recurrence
Time frame: at 2 years after Liver transplantation for HCC (modified by amendment on 17/10/2013)
5 secondary outcomes
Predictive factors of tumor-free recurrence
Time frame: at 3 years
Predictive factors of overall survival at 5 years
Time frame: at 5 years
Predictive factors of drop-out
Time frame: during the waiting time
Radio-pathological correlation
Time frame: end of the study
Correlation of HCC differentiation between liver biopsy and explant liver
Time frame: at 32 month
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 20 Nov 2020.
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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, MD, PhD 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 and Liver Cirrhosis, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 4 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 20 Nov 2020. 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?
Predictive factors of HCC recurrence (time frame: at 2 years after Liver transplantation for HCC (modified by amendment on 17/10/2013)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2020.