Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
Study NCT ID:
NCT04688606
Status:
UNKNOWN
Last Update Posted:
2020-12-30
First Post:
2020-12-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Circulating Tumor Cell Capture for Early Diagnosis and Postoperative Tumor Recurrence Monitoring of Liver Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009360', 'term': 'Neoplastic Cells, Circulating'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2021-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-24', 'studyFirstSubmitDate': '2020-12-24', 'studyFirstSubmitQcDate': '2020-12-24', 'lastUpdatePostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical detection of circulating tumor cells', 'timeFrame': '2020.01.20-2021.02.28', 'description': 'To evaluate the specificity of CTCs for liver cancer screening and the feasibility of early recurrence after interventional therapy, tumor resection or liver transplantation'}], 'secondaryOutcomes': [{'measure': 'Circulating tumor cell function detection and verification', 'timeFrame': '2020.03.01-2021.05.20', 'description': 'Analyze the correlation between circulating tumor cells and clinical prognosis after liver cancer surgery and further mechanism exploration'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Circulating tumor cells, hepatocellular carcinoma'], 'conditions': ['Circulating Tumor Cell']}, 'descriptionModule': {'briefSummary': 'Through the screening of CTCs in patients with suspected liver cancer and liver tumor resection or liver transplantation, the number of CTCs in the blood of liver cancer patients before and after surgery is monitored, and the clinical application significance of CTCs in liver cancer screening and postoperative recurrence monitoring in liver cancer patients is evaluated.', 'detailedDescription': "1. Screen patients with suspected liver cancer Long-term exposure to liver cancer risk factors (hepatitis B carriers, past history of schistosomiasis, long-term diet of Aspergillus food, history of liver cirrhosis, etc.), patients with liver cancer are initially suspected.\n2. Monitor the number of CTCs in the blood of patients with liver cancer before and after surgery Imaging examinations show that liver space is occupied by patients with suspected liver cancer. Use CTCBIOPSY® technology to monitor patients' surgical operations (including interventional therapy, tumor resection, or liver cancer liver transplantation) at different times 1-3 days before, 1 month after surgery, and 6 months after surgery The number of CTCs in peripheral blood.\n3. To evaluate the clinical application significance of CTCs in liver cancer screening and postoperative recurrence monitoring in patients with liver cancer Combined with clinicopathology, tumor marker examination and imaging examination, clinical follow-up and follow-up, analyze the clinical significance of CTCs detection in liver cancer patients, and focus on evaluating the relationship between circulating tumor cells in liver cancer screening and postoperative recurrence, and establish a new The liver cancer prediction model improves the prognosis of liver cancer patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '1. Primary diagnosis of suspected hepatocellular carcinoma; or liver cancer patients who have undergone liver transplantation, radical resection or ablation of liver cancer;\n2. Age 18-75 years old;\n3. ASA (risk of anesthesia) score I-II;\n4. The ECOG score is 0-1;', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Primary diagnosis of suspected hepatocellular carcinoma; or liver cancer patients who have undergone liver transplantation, radical resection or ablation of liver cancer;\n2. Age 18-75 years old;\n3. ASA (risk of anesthesia) score I-II;\n4. The ECOG score is 0-1;\n\nExclusion Criteria:\n\n1. In addition to hepatocellular carcinoma, patients diagnosed with other types of tumors;\n2. Patients with extrahepatic or lymphatic metastasis;\n3. Patients who still have serious complications 4 weeks after surgery;\n4. Patients who cannot provide informed consent;'}, 'identificationModule': {'nctId': 'NCT04688606', 'briefTitle': 'Circulating Tumor Cell Capture for Early Diagnosis and Postoperative Tumor Recurrence Monitoring of Liver Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Zhongnan Hospital'}, 'officialTitle': 'Zhongnan Hospital of Wuhan University', 'orgStudyIdInfo': {'id': '2020108'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Two groups', 'description': '1. Initial diagnosis of suspected hepatocellular carcinoma;\n2. patients undergoing liver transplantation, radical resection or ablation of liver cancer', 'interventionNames': ['Diagnostic Test: Circulating tumor cell capture technology']}], 'interventions': [{'name': 'Circulating tumor cell capture technology', 'type': 'DIAGNOSTIC_TEST', 'description': 'CTCBIOPSY® automatic testing platform', 'armGroupLabels': ['Two groups']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430071', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qifa Ye', 'role': 'CONTACT', 'email': '190679136@qq.com', 'phone': '+86-02767812988'}, {'name': 'Qifa Ye, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongnan Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Qifa Ye', 'role': 'CONTACT', 'email': '190679136@qq.com', 'phone': '+86-02767812988'}, {'name': 'Wenjin Liang', 'role': 'CONTACT', 'email': '190679136@qq.com', 'phone': '+86-02767812988'}], 'overallOfficials': [{'name': 'Qifa Ye', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wuhan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongnan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}