Liver TransplantationNCT02995096
Tumor Characteristics, Pre-transplant Treatments and Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma
An observational study of Liver Transplantation, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
Recurrence after liver transplantation for hepatocellular carcinoma (HCC) represents an important cause of mortality for this surgical population. In addition to tumor characteristics, It has been suggested that pre-treatment and sirolimus-based immunosuppression may affect recurrence and survival. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Pre-treatment and Sirolimus based immunosuppression
- Type of treatment
- Surgery or procedure
- How many people
- 23,124 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Mar 2019
- How long will I take part?
- 3 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients receiving liver transplantation for hepatocellular carcinoma in European centers reporting to the ELTR database.
Who may be able to join
- Hepatocellular carcinoma within transplantation criteria
Who cannot join
- Disseminated disease
About this study
Official title: The Effect of Tumor Characteristics, Pre-transplant Treatments and Immunosuppression on Survival After Liver Transplantation for Hepatocellular Carcinoma - a European Registry Study
Recurrence after liver transplantation for hepatocellular carcinoma (HCC) represents an important cause of mortality for this surgical population. In addition to tumor characteristics, It has been suggested that pre-treatment and sirolimus-based immunosuppression may affect recurrence and survival. With data from the European Liver Transplant Registry (ELTR) database, the aim of this study is to investigate the impact of tumor characteristics, pre-transplant treatment and immunosuppression regimens on survival after liver transplantation for HCC.
- Conditions
- Liver Transplantation
- Being tested
- Pre-treatment, Sirolimus based immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-treatmentProcedure or surgery
Non-transplantation pre-treatments prior to transplantation (e.g. radiofrequency ablation, transcatheter arterial chemoembolization)
Sirolimus based immunosuppressionDrug
Immunosuppression regimens containing Sirolimus
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: up to 10 year survival
Secondary outcomes (1)
Hepatocellular carcinoma specific survival
Measured: 5 year and 10 year survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 23,124 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hans-Christian Pommergaard, MD, PhD, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Hans-Christian Pommergaard, MD, PhD, Principal investigator, Dept. of Surgery and Transplantion, Rigshospitalet, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995096
- Sponsor's protocol ID
- There is no unique protocol ID
- Status last verified
- Mar 2019
- First submitted
- 14 Dec 2016
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The database material is available for researcher applying for data
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tumor Characteristics, Pre-transplant Treatments and Immunosuppression on Survival After Liver Transplantation for Hepatocellular Carcinoma - a European Registry Study
- ClinicalTrials.gov ID
- NCT02995096
- Acronym / sponsor ID
- There is no unique protocol ID
- Conditions
- Liver Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23,124 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 16 Dec 2016 (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.
Recurrence after liver transplantation for hepatocellular carcinoma (HCC) represents an important cause of mortality for this surgical population. In addition to tumor characteristics, It has been suggested that pre-treatment and sirolimus-based immunosuppression may affect recurrence and survival. With data from the European Liver Transplant Registry (ELTR) database, the aim of this study is to investigate the impact of tumor characteristics, pre-transplant treatment and immunosuppression regimens on survival after liver transplantation for HCC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving liver transplantation for hepatocellular carcinoma in European centers reporting to the ELTR database.
Key inclusion criteria (1 listed)
- Hepatocellular carcinoma within transplantation criteria
Key exclusion criteria (1 listed)
- Disseminated disease
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 |
|---|---|---|
| Pre-treatmentNon-transplantation pre-treatments prior to transplantation (e.g. radiofrequency ablation, transcatheter arterial chemoembolization) | Procedure or surgery | – |
| Sirolimus based immunosuppressionImmunosuppression regimens containing Sirolimus | Drug | – |
Primary outcome
Overall survival
Time frame: up to 10 year survival
1 secondary outcome
Hepatocellular carcinoma specific survival
Time frame: 5 year and 10 year survival
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 2 Apr 2019.
- Individual participant dataSharing planned: No. The database material is available for researcher applying for data
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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.
Hans-Christian Pommergaard, MD, PhD principal investigator
Dept. of Surgery and Transplantion, Rigshospitalet, Denmark
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation, run by Copenhagen University Hospital, Rigshospitalet.
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 1 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 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Overall survival (time frame: up to 10 year survival). 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 2 Apr 2019.