Hepatocellular CarcinomaHCCISNCT02718235
Prospective, Multicenter HCCIS Evaluation Study
An observational study of Hepatocellular Carcinoma, run by University of Regensburg.
Trial summary
With this prospective, multicenter trial the investigators aim to establish the Hepatocellular Immune Score (HCCIS), a score that has been developed in a retrospective study, as a new tool for risk stratification of patients after resection of hepatocellular carcinoma that can be widely used in the clinical practice. 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?
- Overall survival
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2021
- 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: Patients >18 years old who are receiving primary liver resection in curative intent for HCC after informed consent is obtained.
Who may be able to join
- Patients >18 years old who are receiving primary liver resection in curative intent for HCC after informed consent is obtained.
Who cannot join
- Patients who have not given informed consent or who have withdrawn their consent will be excluded from this analysis. In case there is not enough liver tissue for a histological analysis or the remaining liver tissue is not enough to perform a routine pathological analysis patients have to be excluded from the further analysis. In case of an R1 or R2 resection, patients have to be excluded from further analysis. However, these patients will remain in the study as an intention to treat analysis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective, Multicenter Study to Evaluate the HCCIS as Prognosticator for Overall and Disease-free Survival of Patients After Resection of HCC
With this prospective, multicenter trial the investigators aim to establish the Hepatocellular Immune Score (HCCIS), a score that has been developed in a retrospective study, as a new tool for risk stratification of patients after resection of hepatocellular carcinoma that can be widely used in the clinical practice. The investigators expect to show that this score is a prognosticator for overall survival and also disease free survival. Further, it should be demonstrated that the HCCIS is a risk stratification tool that is independent from clinical or descriptive parameters. Additionally, the investigators plan to elucidate that the respective HCCIS risk groups are not only different with respect to immunological infiltration but are also different with respect to tumor biology. The finding, that tumors of the respective risk groups show different tumor biology leads to the assumption that different therapy strategies need to be applied. Therefore, in a translational approach we aim to build up a data base with HCC tumor organoids and test the effect of CD8+IL-33+ effector-memory cells on HCC tumor organoids of the respective HCCIS risk groups.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Overall survival
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overall survivalOther
Observation of overall and disease free survival
| Study group | Role | What they receive |
|---|---|---|
| Overall survival HCCIS low risk | HCCIS 2 points Receives: Other: Overall survival | |
| Overall survival HCCIS medium risk | HCCIS 1 point Receives: Other: Overall survival | |
| Overall survival HCCIS high risk | HCCIS 0 point Receives: Other: Overall survival |
What is being measured
The primary outcome is the main question the study is designed to answer.
The HCC immune score (HCCIS) is a survival prognosticator of patients after liver resection for HCC
Overall survival
Measured: 3 years
Secondary outcomes (1)
The HCC immune score (HCCIS) to prognosticate disease free survival of patients after liver resection for HCC
Disease free survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
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.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Collaborators
- Else Kröner Fresenius Foundation
- Responsible party
- Principal investigator, Stefan Brunner, University of Regensburg
- Investigators
- Stefan M Brunner, MD, Principal investigator, Department of Surgery, University Medical Center Regensburg, Regensburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718235
- Sponsor's protocol ID
- HCCIS16
- Acronym
- HCCIS
- Status last verified
- Mar 2016
- First submitted
- 5 Mar 2016
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter Study to Evaluate the HCCIS as Prognosticator for Overall and Disease-free Survival of Patients After Resection of HCC
- ClinicalTrials.gov ID
- NCT02718235
- Acronym / sponsor ID
- HCCIS / HCCIS16
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Collaborators
- Else Kröner Fresenius Foundation
- Study start
- Jun 2016
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 24 Mar 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.
With this prospective, multicenter trial the investigators aim to establish the Hepatocellular Immune Score (HCCIS), a score that has been developed in a retrospective study, as a new tool for risk stratification of patients after resection of hepatocellular carcinoma that can be widely used in the clinical practice. The investigators expect to show that this score is a prognosticator for overall survival and also disease free survival. Further, it should be demonstrated that the HCCIS is a risk stratification tool that is independent from clinical or descriptive parameters. Additionally, the investigators plan to elucidate that the respective HCCIS risk groups are not only different with respect to immunological infiltration but are also different with respect to tumor biology. The finding, that tumors of the respective risk groups show different tumor biology leads to the assumption that different therapy strategies need to be applied. Therefore, in a translational approach we aim to build up a data base with HCC tumor organoids and test the effect of CD8+IL-33+ effector-memory cells on HCC tumor organoids of the respective HCCIS risk groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Overall survival HCCIS low risk | – | Other: Overall survivalHCCIS 2 points |
| Overall survival HCCIS medium risk | – | Other: Overall survivalHCCIS 1 point |
| Overall survival HCCIS high risk | – | Other: Overall survivalHCCIS 0 point |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients >18 years old who are receiving primary liver resection in curative intent for HCC after informed consent is obtained.
Key inclusion criteria (1 listed)
- Patients >18 years old who are receiving primary liver resection in curative intent for HCC after informed consent is obtained.
Key exclusion criteria (1 listed)
- Patients who have not given informed consent or who have withdrawn their consent will be excluded from this analysis. In case there is not enough liver tissue for a histological analysis or the remaining liver tissue is not enough to perform a routine pathological analysis patients have to be excluded from the further analysis. In case of an R1 or R2 resection, patients have to be excluded from further analysis. However, these patients will remain in the study as an intention to treat analysis.
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 |
|---|---|---|
| Overall survivalObservation of overall and disease free survival | Other | Overall survival HCCIS high risk, Overall survival HCCIS low risk, Overall survival HCCIS medium risk |
Primary outcome
The HCC immune score (HCCIS) is a survival prognosticator of patients after liver resection for HCC
Time frame: 3 years
Overall survival
1 secondary outcome
The HCC immune score (HCCIS) to prognosticate disease free survival of patients after liver resection for HCC
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- 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.
Stefan M Brunner, MD principal investigator
Department of Surgery, University Medical Center Regensburg, Regensburg, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by University of Regensburg.
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: status not confirmed, as of the sponsor's last update on 24 Mar 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan M Brunner, MD (00491711752911, stefan.brunner@ukr.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The HCC immune score (HCCIS) is a survival prognosticator of patients after liver resection for HCC (time frame: 3 years). 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 24 Mar 2016.