Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-02-03 @ 4:38 AM
Study NCT ID:
NCT06559761
Status:
RECRUITING
Last Update Posted:
2024-08-19
First Post:
2024-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Image Driven Hepatocellular Carcinoma Invasiveness Evaluation Research
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006498', 'term': 'Hepatectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Resected tumor specimen will be used for histological assessment and DNA/mRNA sequencing'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2024-08-06', 'studyFirstSubmitQcDate': '2024-08-14', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'OS was defined as death related to any cause and was indexed from the date of ablation or surgery until last contact or death'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'DFS was defined as the time interval between first treatment and recurrence or death, whichever occurred earlier'}, {'measure': 'Imaging features', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'MRI or ultrasound Imaging features of the four types'}, {'measure': 'Quantification of immune cells of the resected liver tumour', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Quantification of immune cells of the resected liver tumour using HE staining and immunohistological staining to assess molecular marker and cell infiltration in tumor and liver parenchyma'}, {'measure': 'mRNA sequencing data of the resected liver tumour and peritumor parenchyma', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'mRNA sequencing data of the resected liver tumour and peritumor parenchyma specimen to assess the gene enrichment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatocellular Carcinoma', 'Prognosis', 'Imaging', 'Gross classification'], 'conditions': ['Hepatocellular Carcinoma Stage III']}, 'descriptionModule': {'briefSummary': 'Hepatocellular carcinoma (HCC) is a highly heterogeneous malignant tumor with significant differences in invasion, proliferation ability and patient prognosis. Currently, there is a lack of non-invasive and simple indicators to predict the prognosis of HCC patients and assist clinical decision-making. The identification of HCC macroscopic or histopathological classification requires large pathological specimens obtained through surgical resection, but only about 20% of patients are eligible for surgical treatment. Moreover, most liver cancer diagnoses can be confirmed by imaging examinations without relying on pathological results. For patients who have not undergone surgical resection, the lack of histopathological information during treatment means that there is no basis for judging tumor proliferation and obtaining rich prognostic information. Therefore, evaluating the invasion and proliferation ability of HCC based on macroscopic imaging assessment has important implications for guiding individualized diagnosis and treatment throughout the entire process including surgical strategy guidance, local treatment selection, systemic therapy planning as well as patient follow-up and prognosis evaluation.\n\nUltrasound and MRI are ideal entry points as first-line imaging methods for liver cancer diagnosis. This study aims to evaluate HCC macroscopic or histopathological classification based on multimodal imaging (ultrasound, CT, MRI), thereby assessing its invasion and proliferation ability which has important implications for guiding individualized diagnosis and treatment throughout the entire process including surgical strategy guidance, local treatment selection, systemic therapy planning as well as patient follow-up and prognosis evaluation.\n\nBy analyzing macroscopic image features we aim to explore their cross-scale correlations with HCC macroscopic classification,histopathological classification,and gene molecular typing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients pathologically diagnosed with hepatocellular carcinoma and underwent curative-intent hepatectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* According to the WHO classification, the pathological diagnosis is hepatocellular carcinoma.\n* The initial treatment is curative-intent hepatectomy.\n* There is no evidence of major vascular/hepatic portal invasion, extrahepatic/lymph node metastasis, or other malignant tumors.\n* Age 18-80 years old.\n\nExclusion Criteria:\n\n· Not meeting any one of the inclusion criteria or being unwilling/unable to follow-up.'}, 'identificationModule': {'nctId': 'NCT06559761', 'briefTitle': 'Image Driven Hepatocellular Carcinoma Invasiveness Evaluation Research', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Image Driven Hepatocellular Carcinoma Invasiveness Evaluation Research', 'orgStudyIdInfo': {'id': 'S2024-423'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TYPE I', 'description': 'Gross classification of resected specimen: single nodule with distinct margin, usually round with complete tumour envelope', 'interventionNames': ['Procedure: Hepatectomy']}, {'label': 'TYPE II', 'description': 'Gross classification of resected specimen: single nodule with extranodular growth, no more than three extranodular points', 'interventionNames': ['Procedure: Hepatectomy']}, {'label': 'TYPE III', 'description': 'Gross classification of resected specimen: a unifocal lesion composed of confluent multiple nodules, distinct boundaries among the nodules', 'interventionNames': ['Procedure: Hepatectomy']}, {'label': 'TYPE IV', 'description': 'Gross classification of resected specimen: infiltrative nodule, with poor demarcated boundary and especially multiple extranodular points', 'interventionNames': ['Procedure: Hepatectomy']}], 'interventions': [{'name': 'Hepatectomy', 'type': 'PROCEDURE', 'description': 'According to guideline recommended procedure of hepatectomy', 'armGroupLabels': ['TYPE I', 'TYPE II', 'TYPE III', 'TYPE IV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ping Liang, Doctor', 'role': 'CONTACT'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Chuan Pang', 'role': 'CONTACT', 'email': 'pcpang117@163.com', 'phone': '18910527022'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Hospital of Jilin University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ping Liang', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}