Hepatocellular Carcinoma, ScirrhousHepatoPredictNCT04499833
HepatoPredict Prognostic Tool for the Decision of Liver Transplant in Hepatocellular Carcinoma
A study testing liver transplant in people with Hepatocellular Carcinoma, Scirrhous and Recurrence Tumor, run by Centro Hospitalar de Lisboa Central at 1 site in Portugal.
Trial summary
Liver transplant is the most effective treatment for hepatocellular carcinoma (HCC) in cirrhosis. Due to organs shortage, the proper selection of patients is imperative. Prevailing clinical morphological models used in most centres (Milan Criteria), can exclude potential candidates and include patients with aggressive… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma, Scirrhous, Recurrence Tumor
- What is being tested?
- liver transplant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePortugal
- Study dates
- 25 Mar 2021to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Hepatocellular carcinoma associated with cirrhosis
- Ages between 18 and 70 years
- Total tumour volume below 500 cm3
- Total number of tumour lesions below 10
- Maximum individual tumour diameter below 10 cm
Who cannot join
- eligible under the "Milan Criteria"
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Centro Hepato-bilio-pancreático e de Transplantação do Hospital Curry Cabral
Lisbon, 1069-166
Hugo Pinto-Marques, MD PhD, +351917302214, hugo.marques3@chlc.min-saude.pt
Luis Pereira-de-Silva, MD PhD, +351213596402 ext. 51402, centro.investigacao@chlc.min-saude.pt
About this study
Official title: Evaluation of the HepatoPredict Prognostic Tool in the Decision of Liver Transplant in Hepatocellular Carcinoma
Liver transplant is the most effective treatment for hepatocellular carcinoma (HCC) in cirrhosis. Due to organs shortage, the proper selection of patients is imperative. Prevailing clinical morphological models used in most centres (Milan Criteria), can exclude potential candidates and include patients with aggressive biological behaviour. To more accurately select candidates for liver transplant, the inclusion of criteria that could predict the behaviour and aggressiveness of tumours, such as molecular markers, might be useful.
The investigators propose the use of a new algorithm (HepatoPredict Prognostic Tool), that combine clinical and molecular criteria that address the biology of tumours, in a single centre prospective, intervention study. Data from the "HepatoPredict genomic signature" are added to the clinical and imagiology algorithm. Based on this tool, patients outside the usual eligibility criteria for liver transplant will be proposed for this treatment. These patients will be transplanted with marginal livers or with livers from patients with Familial Amyloid Polyneuropathy, not competing with patients on the waiting list. Patients will be followed up to 60 months after transplant, to assess survival and HCC recurrence with biannual imagiology screening. Survival and disease-free-survival rates will be compared with those obtained by the usual management of patients included and excluded by Milan Criteria.
Read the detailed description
Liver transplant is the most effective treatment for hepatocellular carcinoma (HCC) in cirrhosis. Due to organs shortage, the proper selection of patients is imperative. Prevailing clinical morphological models used in most centres (Milan Criteria), can exclude potential candidates and include patients with aggressive biological behaviour. To more accurately select candidates for liver transplant, the inclusion of criteria that could predict the behaviour and aggressiveness of tumours, such as molecular markers, might be useful. The investigators propose the use of a new algorithm (HepatoPredict Prognostic Tool, Ophiomics), combining morphologic information, clinical and molecular criteria, in a prospective, intervention, single centre study.
Patients aged 18 to 70 years, with HCC in cirrhosis, not eligible for liver transplant under the "Milan Criteria", whom had the following morphologic characteristics: total tumour volume below 500 cm3, total number of tumour lesions below 10 and maximum individual tumour diameter below 10 cm, will be proposed for the "HepatoPredict genomic signature" analysis (Ophiomics), obtained from DNA of tumor samples. Those considered candidates by the algorithm are to be proposed for transplant with marginal livers or with livers from patients with Familial Amyloid Polyneuropathy.
Patients will be followed up to 60 months after transplant, to assess survival and HCC recurrence with biannual imagiology screening by triphasic CT scan. Additionally, circulating tumour DNA will be assessed previously to the transplant and biannually for up to 60 months. Survival and disease-free-survival rates will be compared with those obtained with the usual management of patients included and excluded by Milan Criteria, both in the same referral transplant center and in the published literature.
- Being tested
- liver transplant
- Keywords
- cirrhosis, Hepatocellular Carcinoma, liver transplant, tumor recurrence, biomarkers, prognosis
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver transplantProcedure or surgery
liver transplant
| Study group | Role | What they receive |
|---|---|---|
| liver transplant outside the "Milan Criteria" | Experimental | patients with hepatocellular carcinoma, outside the "Milan Criteria", that complied with the proposed HepatoPredictTool, submitted to liver transplant Receives: Procedure: liver transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
death by any cause
Measured: from 6 months after liver transplant up to 60 months
hepatocellular carcinoma recurrence
identification of hepatocellular carcinoma recurrence through biannual triphasic CT scan
Measured: from 6 months after liver transplant up to 60 months
Secondary outcomes (1)
hepatocellular carcinoma recurrence through liquid biopsy
early identification of hepatocellular carcinoma DNA through biannual serum samples (liquid biopsy)
Measured: from 6 months after liver transplant up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start25 Mar 2021
- Primary completion30 Oct 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma, ScirrhousStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective evaluation of patients with hepatocellular carcinoma in cirrhotic liver, outside the "Milan Criteria" for liver transplant, that comply with the morphologic criteria stablished for the proposed HepatoPredict Tool: (1) Total tumour volume below 500 cm3; (2) Total number of tumour lesions below 10; and (3) maximum individual tumour diameter below 10 cm. Those patients are proposed to be submitted to molecular study of the hepatocellular carcinoma and, if comply with the "HepatoPredict genomic signature", liver transplantation will be proposed. Patients will be followed up for up to 5 years after transplantation for survival and survival-free-of-disease.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar de Lisboa Central
- Sponsor type
- University, hospital or other
- Collaborators
- Ophiomics - Precision Medicine
- Responsible party
- Sponsor
- Investigators
- Hugo Pinto-Marques, MD PhD, Principal investigator, Centro Hospitalar Universitário de Lisboa Central
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499833
- Sponsor's protocol ID
- CHULC.CI.HCC.2020
- Acronym
- HepatoPredict
- Status last verified
- Jun 2022
- First submitted
- 31 Jul 2020
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the HepatoPredict Prognostic Tool in the Decision of Liver Transplant in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04499833
- Acronym / sponsor ID
- HepatoPredict / CHULC.CI.HCC.2020
- Keywords
- cirrhosis, Hepatocellular Carcinoma, liver transplant, tumor recurrence, biomarkers, prognosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centro Hospitalar de Lisboa CentralUniversity, hospital or other
- Collaborators
- Ophiomics - Precision Medicine
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 5 Aug 2020 (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.
Liver transplant is the most effective treatment for hepatocellular carcinoma (HCC) in cirrhosis. Due to organs shortage, the proper selection of patients is imperative. Prevailing clinical morphological models used in most centres (Milan Criteria), can exclude potential candidates and include patients with aggressive biological behaviour. To more accurately select candidates for liver transplant, the inclusion of criteria that could predict the behaviour and aggressiveness of tumours, such as molecular markers, might be useful.
The investigators propose the use of a new algorithm (HepatoPredict Prognostic Tool), that combine clinical and molecular criteria that address the biology of tumours, in a single centre prospective, intervention study. Data from the "HepatoPredict genomic signature" are added to the clinical and imagiology algorithm. Based on this tool, patients outside the usual eligibility criteria for liver transplant will be proposed for this treatment. These patients will be transplanted with marginal livers or with livers from patients with Familial Amyloid Polyneuropathy, not competing with patients on the waiting list. Patients will be followed up to 60 months after transplant, to assess survival and HCC recurrence with biannual imagiology screening. Survival and disease-free-survival rates will be compared with those obtained by the usual management of patients included and excluded by Milan Criteria.
Detailed description
Liver transplant is the most effective treatment for hepatocellular carcinoma (HCC) in cirrhosis. Due to organs shortage, the proper selection of patients is imperative. Prevailing clinical morphological models used in most centres (Milan Criteria), can exclude potential candidates and include patients with aggressive biological behaviour. To more accurately select candidates for liver transplant, the inclusion of criteria that could predict the behaviour and aggressiveness of tumours, such as molecular markers, might be useful. The investigators propose the use of a new algorithm (HepatoPredict Prognostic Tool, Ophiomics), combining morphologic information, clinical and molecular criteria, in a prospective, intervention, single centre study.
Patients aged 18 to 70 years, with HCC in cirrhosis, not eligible for liver transplant under the "Milan Criteria", whom had the following morphologic characteristics: total tumour volume below 500 cm3, total number of tumour lesions below 10 and maximum individual tumour diameter below 10 cm, will be proposed for the "HepatoPredict genomic signature" analysis (Ophiomics), obtained from DNA of tumor samples. Those considered candidates by the algorithm are to be proposed for transplant with marginal livers or with livers from patients with Familial Amyloid Polyneuropathy.
Patients will be followed up to 60 months after transplant, to assess survival and HCC recurrence with biannual imagiology screening by triphasic CT scan. Additionally, circulating tumour DNA will be assessed previously to the transplant and biannually for up to 60 months. Survival and disease-free-survival rates will be compared with those obtained with the usual management of patients included and excluded by Milan Criteria, both in the same referral transplant center and in the published literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective evaluation of patients with hepatocellular carcinoma in cirrhotic liver, outside the "Milan Criteria" for liver transplant, that comply with the morphologic criteria stablished for the proposed HepatoPredict Tool: (1) Total tumour volume below 500 cm3; (2) Total number of tumour lesions below 10; and (3) maximum individual tumour diameter below 10 cm. Those patients are proposed to be submitted to molecular study of the hepatocellular carcinoma and, if comply with the "HepatoPredict genomic signature", liver transplantation will be proposed. Patients will be followed up for up to 5 years after transplantation for survival and survival-free-of-disease.
| Arm | Type | Receives |
|---|---|---|
| liver transplant outside the "Milan Criteria" | Experimental | Procedure: liver transplantpatients with hepatocellular carcinoma, outside the "Milan Criteria", that complied with the proposed HepatoPredictTool, submitted to liver transplant |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hepatocellular carcinoma associated with cirrhosis
- Ages between 18 and 70 years
- Total tumour volume below 500 cm3
- Total number of tumour lesions below 10
- Maximum individual tumour diameter below 10 cm
Key exclusion criteria (1 listed)
- eligible under the "Milan Criteria"
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 |
|---|---|---|
| liver transplantliver transplant | Procedure or surgery | liver transplant outside the "Milan Criteria" |
Primary outcome
death
Time frame: from 6 months after liver transplant up to 60 months
death by any cause
hepatocellular carcinoma recurrence
Time frame: from 6 months after liver transplant up to 60 months
identification of hepatocellular carcinoma recurrence through biannual triphasic CT scan
1 secondary outcome
hepatocellular carcinoma recurrence through liquid biopsy
Time frame: from 6 months after liver transplant up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Individual participant dataSharing planned: No
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.
Hugo Pinto-Marques, MD PhD principal investigator
Centro Hospitalar Universitário de Lisboa Central
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liver transplant in people with Hepatocellular Carcinoma, Scirrhous and Recurrence Tumor, run by Centro Hospitalar de Lisboa Central at 1 site in Portugal.
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 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: looking for participants now, as of the sponsor's last update on 6 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 Portugal. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hugo Pinto-Marques, MD PhD (+351917302214, hugo.marques3@chlc.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: from 6 months after liver transplant up to 60 months). The study lists 2 primary outcomes in all. 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 6 Jun 2022.