Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-29 @ 9:15 AM
Study NCT ID:
NCT06382103
Status:
RECRUITING
Last Update Posted:
2025-03-26
First Post:
2024-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers and Molecular Mechanism Study of Hepatocellular Carcinoma After Radical Resection and Conversion Therapy
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-23', 'studyFirstSubmitDate': '2024-04-15', 'studyFirstSubmitQcDate': '2024-04-21', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between ctDNA level and recurrence-free survival (RFS)', 'timeFrame': '1 years', 'description': 'ctDNA measurements will be made at baseline and 1 months, 3 months, 6 months, 12 months after surgery. RFS will be assessed by standard radiographic imaging.'}, {'measure': 'Correlation between specific plasma protein expression level and recurrence-free survival (RFS)', 'timeFrame': '1 years', 'description': 'plasma proteomic measurements will be made at baseline and 1 months, 3 months, 6 months, 12 months after surgery. RFS will be assessed by standard radiographic imaging.'}], 'secondaryOutcomes': [{'measure': 'Correlation between tumor mutation numbers and recurrence-free survival (RFS)', 'timeFrame': '1 years', 'description': 'Patients with available tumor tissues were sequenced to identify their specific tumor variants.The correlation of mutation numbers and RFS will be analysis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'Blood samples will be tested to identify circulating tumor DNA and plasma protein levels to potentially improve prediction of long term prognosis and guide treatment options of patients with hepatocellular carcinoma underwent surgical resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will enroll male and female subjects with HCC treated with definitive surgery,with or without neoadjuvant therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a first diagnosis of HCC.\n* Patients with HCC who are to undergo surgical treatment, with or without neoadjuvant therapy.\n* Ability to obtain tissue sample for ctDNA analysis and detectable baseline ctDNA level.\n\nExclusion Criteria:\n\n* Patients with secondary liver cancer, or intrahepatic cholangiocarcinoma.\n* Any other concurrent malignancy.\n* History of organ transplant or hepatic encephalopathy.'}, 'identificationModule': {'nctId': 'NCT06382103', 'briefTitle': 'Biomarkers and Molecular Mechanism Study of Hepatocellular Carcinoma After Radical Resection and Conversion Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Biomarkers and Molecular Mechanism Study of Hepatocellular Carcinoma After Radical Resection and Conversion Therapy', 'orgStudyIdInfo': {'id': 'B2024-108R'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ctDNA monitoring', 'type': 'DIAGNOSTIC_TEST', 'description': 'The ctDNA level will be measured using tumor-informed (Signatera platform) and tumor-naived (fragmentomes measurement) assay.'}, {'name': 'Plasma proteomic analysis', 'type': 'DIAGNOSTIC_TEST', 'description': 'plasma protein level will be measured via Proximity Extension Assay and LC-MS based proteomic analysis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui-Chuan Sun', 'role': 'CONTACT', 'email': 'sun.huichuan@zs-hospital.sh.cn', 'phone': '86+13701922065'}], 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Huichuan Sun', 'role': 'CONTACT', 'email': 'sun.huichuan@zs-hospital.sh.cn', 'phone': '+86-21-64041990'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}