Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-28 @ 7:24 PM
Study NCT ID:
NCT06157060
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2023-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Longitudinal Monitoring MRD Based on ctDNA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 255}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2023-11-23', 'studyFirstSubmitQcDate': '2023-11-27', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-year recurrence-free survival rate', 'timeFrame': '2 years', 'description': 'percentage of recurrence-free survival 2 years after surgery'}], 'secondaryOutcomes': [{'measure': 'Correlation between ctDNA-MRD status dynamic changes and relapse', 'timeFrame': '2 years', 'description': 'Correlation between ctDNA-MRD status dynamic changes and relapse'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma Resectable']}, 'descriptionModule': {'briefSummary': 'This study will conduct a prospective cohort study to verify the predictive value of ctDNA-MRD longitudinal monitoring model in predicting postoperative recurrence, verify whether ctDNA-MRD longitudinal monitoring model can indicate recurrence earlier than imaging examination, and explore the feasibility of guiding adjuvant therapy after curative treatment based on this model.', 'detailedDescription': 'The recurrence rate of hepatocellular carcinoma after curative treatment is high, and the minimal residual disease(MRD) in patients is the major cause of liver cancer recurrence, and the MRD is an important basis for the decision of adjuvant therapy after curative treatment. Previous studies have confirmed that circulating tumor DNA(ctDNA)-MRD monitoring model can accurately predict the recurrence of hepatocellular carcinoma patients. It was also found in retrospective analysis that tumor free survival was significantly prolonged after ctDNA-positive treatment for hepatocellular carcinoma after resection. This study will conduct a prospective cohort study to verify the predictive value of ctDNA-MRD longitudinal monitoring model in predicting postoperative recurrence, verify whether ctDNA-MRD longitudinal monitoring model can indicate recurrence earlier than imaging examination, and explore the feasibility of guiding adjuvant therapy after curative treatment based on this model.This study is to verify the predictive value of ctDNA-MRD longitudinal monitoring model in predicting postoperative recurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with hepatocellular carcinoma who can undergo radical surgical resection', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female patients aged 18-75 years;\n2. Preoperative imaging examination diagnosed hepatocellular carcinoma (BCLC) stage 0 / stage A/stage B, eligible for radical surgery;\n3. ECOG physical status score is 0-1;\n4. Child-Pugh score is 5-6 points (Level A);\n5. Not received any anti-tumor therapy;\n6. Laboratory tests were at normal levels within 7 days before enrollment.\n\nExclusion Criteria:\n\n1. Patient can't provide blood samples for ctDNA testing;\n2. Patient with two or more types of tumors at the same time;\n3. Non-primary liver lesions;\n4. Pregnant or lactating women;\n5. Patient with a history of other malignant tumors within the past 5 years or at the same time, except cured skin basal cell carcinoma, cervical carcinoma in situ and thyroid papillary carcinoma;\n6. Patient with serious heart disease;\n7. Other conditions deemed unsuitable for inclusion by the researcher."}, 'identificationModule': {'nctId': 'NCT06157060', 'briefTitle': 'Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Longitudinal Monitoring MRD Based on ctDNA', 'organization': {'class': 'OTHER', 'fullName': 'Zhujiang Hospital'}, 'officialTitle': 'Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Longitudinal Monitoring Minimal Residual Disease Based on Circulating Tumor DNA', 'orgStudyIdInfo': {'id': '2023-KY-232-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with hepatocellular carcinoma', 'description': 'Patient with hepatocellular carcinoma who can undergo radical resection', 'interventionNames': ['Diagnostic Test: circulating tumor DNA']}], 'interventions': [{'name': 'circulating tumor DNA', 'type': 'DIAGNOSTIC_TEST', 'description': 'blood sample and tissue specimen for circulating tumor DNA will be done to patient with hepatocellular carcinoma', 'armGroupLabels': ['Patient with hepatocellular carcinoma']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Foshan', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weichao Liang, Prof.', 'role': 'CONTACT', 'phone': '13590542927'}, {'name': 'Weichao Liang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Sixth Affiliated Hospital of South China University of Technology', 'geoPoint': {'lat': 23.02677, 'lon': 113.13148}}, {'zip': '510220', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mingxin Pan, Prof.', 'role': 'CONTACT', 'email': 'pmxwxy@sohu.com', 'phone': '18928918216'}, {'name': 'Cheng Zhang, Dr.', 'role': 'CONTACT', 'email': '754167410@qq.com', 'phone': '13242781120'}, {'name': 'Mingxin Pan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhujiang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yinbing Wu, Prof.', 'role': 'CONTACT', 'phone': '18620007296'}, {'name': 'Yinbing Wu, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Affiliated Cancer Hospital and Institute of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junming He, Prof.', 'role': 'CONTACT', 'phone': '13501538271'}, {'name': 'Junming He, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Guangdong Provincial Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weidong Wang, Prof.', 'role': 'CONTACT', 'phone': '13702835586'}, {'name': 'Weidong Wang, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shunde Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rongping Guo, Prof.', 'role': 'CONTACT', 'phone': '18819809988'}, {'name': 'Rongping Guo, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Shaoguan', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qingsong Wu, Prof.', 'role': 'CONTACT', 'phone': '13826368658'}], 'facility': "Yuebei People's Hospital", 'geoPoint': {'lat': 24.8, 'lon': 113.58333}}], 'centralContacts': [{'name': 'Mingxin Pan, Prof.', 'role': 'CONTACT', 'email': 'pmxwxy@sohu.com', 'phone': '+8618928918216'}, {'name': 'Cheng Zhang', 'role': 'CONTACT', 'email': '754167410@qq.com', 'phone': '13242781120'}], 'overallOfficials': [{'name': 'Mingxin Pan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southern Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhujiang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}