Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-05 @ 10:21 AM
Study NCT ID:
NCT07466602
Status:
RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
cfDNA Methylation for Liver Cancer Recurrence Detection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sensitivity', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'specificity', 'timeFrame': 'Through study completion, an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Liver Cancer']}, 'descriptionModule': {'briefSummary': "Through follow-up testing of patients with primary liver cancer who underwent hepatectomy, liver transplantation, ablation therapy, or transarterial chemoembolization (TACE), a blinded comparative trial was conducted at each monitoring site. This trial evaluated the combined methylation detection kit for GNB4 and Riplet genes (fluorescent PCR method) against the clinical reference standard (defined as the physician's comprehensive diagnosis based on clinical guidelines and other criteria). The study evaluated the clinical performance of the assay in diagnosing primary liver cancer recurrence and validated the clinical efficacy of methylation detection kits for monitoring recurrence after primary liver cancer treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study investigates patients with primary liver cancer, encompassing three types: hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and mixed liver cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary liver cancer\n\nExclusion Criteria:\n\n* Concurrent other malignant tumors;\n* Ineligible for hepatectomy, liver transplantation, ablation, or TACE therapy;\n* Negative methylation status prior to treatment.'}, 'identificationModule': {'nctId': 'NCT07466602', 'briefTitle': 'cfDNA Methylation for Liver Cancer Recurrence Detection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wuhan Ammunition Life-tech Co., Ltd'}, 'officialTitle': 'Clinical Study on the Combined Detection of Plasma GNB4 and Riplet Gene Methylation for Monitoring Primary Liver Cancer Recurrence', 'orgStudyIdInfo': {'id': 'AD07-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary liver cancer patients', 'interventionNames': ['Diagnostic Test: plasma GNB4 and Riplet genes methylation detection']}], 'interventions': [{'name': 'plasma GNB4 and Riplet genes methylation detection', 'type': 'DIAGNOSTIC_TEST', 'description': 'Liver cancer patients undergo methylation testing at different follow-up time points after treatment', 'armGroupLabels': ['Primary liver cancer patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zeyang Ding, MD', 'role': 'CONTACT', 'email': 'zyding@tjh.tjmu.edu.cn', 'phone': '+86 13407156200'}, {'name': 'Wanguang Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zeyang Ding, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shuai Xiang, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Zhao Huang, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Tingting Li, phD', 'role': 'CONTACT', 'email': 'litingting@amswh.com', 'phone': '+86 13317163570'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuhan Ammunition Life-tech Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}