Prospective, Multicenter HCCIS Evaluation Study
HCCIS
Prospective, Multicenter Study to Evaluate the HCCIS as Prognosticator for Overall and Disease-free Survival of Patients After Resection of HCC
1 other identifier
observational
200
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2016
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2016
CompletedFirst Posted
Study publicly available on registry
March 24, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedMarch 24, 2016
March 1, 2016
5 years
March 5, 2016
March 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
The HCC immune score (HCCIS) is a survival prognosticator of patients after liver resection for HCC
Overall survival
3 years
Secondary Outcomes (1)
The HCC immune score (HCCIS) to prognosticate disease free survival of patients after liver resection for HCC
3 years
Study Arms (3)
Overall survival HCCIS low risk
HCCIS 2 points
Overall survival HCCIS medium risk
HCCIS 1 point
Overall survival HCCIS high risk
HCCIS 0 point
Interventions
Observation of overall and disease free survival
Eligibility Criteria
Patients \>18 years old who are receiving primary liver resection in curative intent for HCC after informed consent is obtained.
You may qualify if:
- Patients \>18 years old who are receiving primary liver resection in curative intent for HCC after informed consent is obtained.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Regensburglead
- Else Kröner Fresenius Foundationcollaborator
Biospecimen
Tumor tissue for immunohistochemical analysis
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan M Brunner, MD
Department of Surgery, University Medical Center Regensburg, Regensburg, Germany
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr. med. Stefan M. Brunner
Study Record Dates
First Submitted
March 5, 2016
First Posted
March 24, 2016
Study Start
June 1, 2016
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
March 24, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share