Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-01-02 @ 12:44 PM
Study NCT ID:
NCT02718235
Status:
UNKNOWN
Last Update Posted:
2016-03-24
First Post:
2016-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective, Multicenter HCCIS Evaluation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Tumor tissue for immunohistochemical analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-23', 'studyFirstSubmitDate': '2016-03-05', 'studyFirstSubmitQcDate': '2016-03-23', 'lastUpdatePostDateStruct': {'date': '2016-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The HCC immune score (HCCIS) is a survival prognosticator of patients after liver resection for HCC', 'timeFrame': '3 years', 'description': 'Overall survival'}], 'secondaryOutcomes': [{'measure': 'The HCC immune score (HCCIS) to prognosticate disease free survival of patients after liver resection for HCC', 'timeFrame': '3 years', 'description': 'Disease free survival'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients \\>18 years old who are receiving primary liver resection in curative intent for HCC after informed consent is obtained.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>18 years old who are receiving primary liver resection in curative intent for HCC after informed consent is obtained.\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT02718235', 'acronym': 'HCCIS', 'briefTitle': 'Prospective, Multicenter HCCIS Evaluation Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Regensburg'}, 'officialTitle': 'Prospective, Multicenter Study to Evaluate the HCCIS as Prognosticator for Overall and Disease-free Survival of Patients After Resection of HCC', 'orgStudyIdInfo': {'id': 'HCCIS16'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Overall survival HCCIS low risk', 'description': 'HCCIS 2 points', 'interventionNames': ['Other: Overall survival']}, {'label': 'Overall survival HCCIS medium risk', 'description': 'HCCIS 1 point', 'interventionNames': ['Other: Overall survival']}, {'label': 'Overall survival HCCIS high risk', 'description': 'HCCIS 0 point', 'interventionNames': ['Other: Overall survival']}], 'interventions': [{'name': 'Overall survival', 'type': 'OTHER', 'description': 'Observation of overall and disease free survival', 'armGroupLabels': ['Overall survival HCCIS high risk', 'Overall survival HCCIS low risk', 'Overall survival HCCIS medium risk']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Stefan M Brunner, MD', 'role': 'CONTACT', 'email': 'stefan.brunner@ukr.de', 'phone': '00491711752911'}], 'overallOfficials': [{'name': 'Stefan M Brunner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgery, University Medical Center Regensburg, Regensburg, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Regensburg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Else Kröner Fresenius Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med. Stefan M. Brunner', 'investigatorFullName': 'Stefan Brunner', 'investigatorAffiliation': 'University of Regensburg'}}}}