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Prospective, Multicenter HCCIS Evaluation Study

NCT02718235 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2016-03-24

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Overall survival

Observation of overall and disease free survival

Sponsors & Collaborators

  • Else Kröner Fresenius Foundation

    collaborator OTHER

  • University of Regensburg

    lead OTHER

Principal Investigators

  • Stefan M Brunner, MD · Department of Surgery, University Medical Center Regensburg, Regensburg, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2021-06-30
Completion
2021-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02718235 on ClinicalTrials.gov