Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-02-27 @ 7:06 PM
Study NCT ID:
NCT03277651
Status:
UNKNOWN
Last Update Posted:
2018-01-10
First Post:
2017-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Noninvasive Diagnostic Platform for Liver Fibrosis and Portal Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-09', 'studyFirstSubmitDate': '2017-09-04', 'studyFirstSubmitQcDate': '2017-09-08', 'lastUpdatePostDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity', 'timeFrame': 'baseline', 'description': 'Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension'}, {'measure': 'Specificity', 'timeFrame': 'baseline', 'description': 'Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension'}, {'measure': 'Positive predictive value (PPV)', 'timeFrame': 'baseline', 'description': 'Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension'}, {'measure': 'Negative predictive value (NPV)', 'timeFrame': 'baseline', 'description': 'Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension'}, {'measure': 'Area under ROC curve (AUROC)', 'timeFrame': 'baseline', 'description': 'Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['noninvasive', 'Hemodynamics'], 'conditions': ['Liver Fibrosis', 'Cirrhosis', 'Portal Hypertension']}, 'referencesModule': {'references': [{'pmid': '40896458', 'type': 'DERIVED', 'citation': 'Zheng L, Shi N, Li P, Ge H, Tu C, Qu Y, Wang Y, Lin Y, Chen S, Sun D, Weng C, Wu S, Jiang W. Development and validation of machine learning models to predict esophagogastric variceal rebleeding risk in HBV-related cirrhosis after endoscopic treatment: a prospective multicenter study. EClinicalMedicine. 2025 Aug 20;87:103436. doi: 10.1016/j.eclinm.2025.103436. eCollection 2025 Sep.'}]}, 'descriptionModule': {'briefSummary': 'This study is to establish a noninvasive diagnostic platform based on hemodynamic information for the assessment of liver fibrosis, liver cirrhosis and portal hypertension.', 'detailedDescription': "As the hemodynamics of liver vessels depend on the liver tissue mechanics, we hypothesize that the hemodynamics measurements of the liver are strongly correlated with the stages of liver fibrosis and portal hypertension, and can therefore serve as an alternative means of diagnosis. We have developed a physics-based mathematical model that incorporates our biological understanding of fibrosis development. The model quantitatively predicts changes of liver tissue stiffness and blood flow dynamics as a function of fibrosis stage. Preliminary data using ultrasound Doppler images and needle biopsy from liver fibrosis patients have suggested the 'prove of principle. We propose further test our hypothesis by collecting and analyzing ultrasound Doppler and biopsy data to confirm the correlation between blood flow dynamics and disease stage from patients with hepatic fibrosis and portal hypertension. If tested true, we can expect to use features of ultrasound Doppler as a non-invasive means of diagnosis for fibrosis and portal hypertension."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Inpatients who undergo liver biopsy or hepatic venous pressure gradient test in Zhongshan hospital Fudan University', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatients who undergo liver biopsy or hepatic venous pressure gradient test\n\nExclusion Criteria:\n\n* decompensated liver diseases (including ascites, variceal bleeding or hepatic encephalopathy);\n* alpha-fetoprotein \\>100 ng/ml or serum creatinine \\>1.5 × upper limit of normal (ULN);\n* any malignant tumor;\n* any complications of severe heart, lung, kidney, brain, blood diseases or other important systematic diseases;\n* severe neurological or psychological disease;\n* pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT03277651', 'briefTitle': 'Noninvasive Diagnostic Platform for Liver Fibrosis and Portal Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Developing a Hemodynamics Based Noninvasive Diagnostic Platform for Liver Fibrosis/Cirrhosis and Portal Hypertension', 'orgStudyIdInfo': {'id': 'Hemodynamics Models for CLD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'liver fibrosis', 'description': 'liver biopsy proved', 'interventionNames': ['Diagnostic Test: hemodynamics tests']}, {'label': 'portal hypertension', 'description': 'hepatic venous pressure gradient (HVPG) proved', 'interventionNames': ['Diagnostic Test: hemodynamics tests']}], 'interventions': [{'name': 'hemodynamics tests', 'type': 'DIAGNOSTIC_TEST', 'description': 'Hemodynamics tests for intrahepatic blood flow by colour doppler ultrasound', 'armGroupLabels': ['liver fibrosis', 'portal hypertension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shengdi Wu, M.D.', 'role': 'CONTACT', 'email': 'wu.shengdi@zs-hospital.sh.cn'}], 'facility': 'Zhongshan Hospital affiliated to Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Shengdi Wu', 'role': 'CONTACT', 'email': 'wu.shengdi@zs-hospital.sh.cn', 'phone': '0086-021-64041990'}, {'name': 'Wei Jiang', 'role': 'CONTACT', 'email': 'jiang.wei@zs-hospital.sh.cn', 'phone': '0086-021-64041990'}], 'overallOfficials': [{'name': 'Wei Jiang', 'role': 'STUDY_CHAIR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}