Prospective, Multicenter HCCIS Evaluation Study

NCT ID: NCT02718235

Last Updated: 2016-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Overall survival HCCIS low risk

HCCIS 2 points

Overall survival

Intervention Type OTHER

Observation of overall and disease free survival

Overall survival HCCIS medium risk

HCCIS 1 point

Overall survival

Intervention Type OTHER

Observation of overall and disease free survival

Overall survival HCCIS high risk

HCCIS 0 point

Overall survival

Intervention Type OTHER

Observation of overall and disease free survival

Interventions

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Overall survival

Observation of overall and disease free survival

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients \>18 years old who are receiving primary liver resection in curative intent for HCC after informed consent is obtained.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Else Kröner Fresenius Foundation

OTHER

Sponsor Role collaborator

University of Regensburg

OTHER

Sponsor Role lead

Responsible Party

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Stefan Brunner

PD Dr. med. Stefan M. Brunner

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan M Brunner, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, University Medical Center Regensburg, Regensburg, Germany

Central Contacts

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Stefan M Brunner, MD

Role: CONTACT

00491711752911

Other Identifiers

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HCCIS16

Identifier Type: -

Identifier Source: org_study_id

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