Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-29 @ 11:34 PM
Study NCT ID:
NCT06524557
Status:
RECRUITING
Last Update Posted:
2024-07-29
First Post:
2024-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploration of Noninvasive Differential Diagnosis of Benign and Malignant Liver Tumors
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': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-23', 'studyFirstSubmitDate': '2024-07-23', 'studyFirstSubmitQcDate': '2024-07-23', 'lastUpdatePostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The differential diagnosis of liver tumors', 'timeFrame': '2018.01-2025.12', 'description': 'Multimodal ultrasound is of great value in the differential diagnosis of liver tumors'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['liver tumors', 'benign', 'malignant', 'Differential diagnosis'], 'conditions': ['Liver Tumor']}, 'referencesModule': {'references': [{'pmid': '40231713', 'type': 'DERIVED', 'citation': 'Zhou H, Sang L, Sun Y, Gong X, Zhang J, Liu L, Wei J, Jiao W, Yu M. Performance of Ultrasonography-Based Fractal Parameters in Distinguishing Hepatocellular Carcinoma From Intrahepatic Cholangiocarcinoma. Ultrason Imaging. 2025 Jul;47(3-4):115-124. doi: 10.1177/01617346251330257. Epub 2025 Apr 15.'}]}, 'descriptionModule': {'briefSummary': 'To explore an effective noninvasive method for differential diagnosis of liver tumors.', 'detailedDescription': 'A retrospective study was performed to assess the performance of certain ultrasound-based parameters, in distinguishing benign from malignant with liver biopsy as the gold standard. Demographic data, clinical information and serological data were obtained from participants who were retrospectively enrolled. Receiver operating characteristic (ROC) curve analysis was conducted, including calculation of the optimal area under the ROC curve (AUC), to assess the performance of these measures in distinguishing between benign and malignant in patients with or without chronic liver disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 200 patients whose pathological diagnoses were confirmed by US-guided liver biopsy or surgery and who underwent preoperative conventional US between January 2018 and November 2025 were enrolled in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(1) age 18-70 years; (2) liver examination performed for all patients prior to US-guided liver biopsy or surgery; (3) tumor can be visualized in conventional US; (4) largest tumor sectional area saved in DICOM format for use in later analyses; (5) a histopathological diagnosis made either from US-guided liver biopsy or surgical resection; (6) suitable routine clinical and US data obtained within 7 days of the histopathological diagnosis.\n\nExclusion Criteria:\n\n(1) unavailable pathological diagnosis; (2) liver metastatic tumors; (3) poor quality US images; and (4) a past history of surgical resection, percutaneous local ablation, radiation, transarterial and systemic therapies or liver transplantation.'}, 'identificationModule': {'nctId': 'NCT06524557', 'briefTitle': 'Exploration of Noninvasive Differential Diagnosis of Benign and Malignant Liver Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Department of Ultrasonic Medicine, The First Affiliated Hospital of Air Force Medical University', 'orgStudyIdInfo': {'id': 'KY-20180101-3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'with chronic liver disease', 'description': 'patients with hepatitis B virus, hepatitis C virus and other chronic liver disease.', 'interventionNames': ['Diagnostic Test: with chronic liver disease']}, {'label': 'without chronic liver disease', 'description': 'patients without hepatitis B virus, hepatitis C virus and other chronic liver disease.'}], 'interventions': [{'name': 'with chronic liver disease', 'type': 'DIAGNOSTIC_TEST', 'description': 'patients with hepatitis B virus，hepatitis C virus, or other chronic liver disease', 'armGroupLabels': ['with chronic liver disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': "Xi'an", 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhou Huihui, M.M.', 'role': 'CONTACT', 'email': 'huihui2807201830@163.com', 'phone': '15209239680'}], 'facility': 'Xijing Hosptial', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Zhou Huihui, M.M.', 'role': 'CONTACT', 'email': 'huihui2807201830@163.com', 'phone': '15209239680'}], 'overallOfficials': [{'name': 'Zhou Huihui, M.M.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Ultrasonic Medicine, The First Affiliated Hospital of Air Force Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}