Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-29 @ 3:23 AM
Study NCT ID:
NCT06500403
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Tools for PSVD Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094724', 'term': 'Idiopathic Noncirrhotic Portal Hypertension'}], 'ancestors': [{'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-08', 'studyFirstSubmitDate': '2024-07-08', 'studyFirstSubmitQcDate': '2024-07-08', 'lastUpdatePostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Searching for valid non-invasive tools for the diagnosis of PSVD', 'timeFrame': '2 years', 'description': 'The sensitivity and specificity of the non-invasive models for the diagnosis of PSVD reached 85% and 60%, respectively'}], 'secondaryOutcomes': [{'measure': 'Patients developed portal-hypertension-related complications', 'timeFrame': '3 years', 'description': 'clinically significant ascites, esophagogastric variceal hemorrhage, hepatic encephalopathy, etc.'}, {'measure': 'Patients died', 'timeFrame': '3 years', 'description': 'All-cause death'}, {'measure': 'Patients underwent liver transplantation', 'timeFrame': '3 years', 'description': 'Patients underwent liver transplantation during follow up'}, {'measure': 'Patients reached the final follow-up time', 'timeFrame': '3 years', 'description': 'Patients had accepted 3-year follow up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Cirrhotic Portal Hypertension', 'Porto-Sinusoidal Vascular Diseases']}, 'descriptionModule': {'briefSummary': 'Patients treated with platinum-based chemotherapy drugs have the probability of developing PSVD. The diagnosis of PSVD depends on liver biopsy. In addition, the level of portal vein pressure has guiding value in the diagnosis and prognosis of PSVD. Many studies have shown that liver and spleen stiffness have high accuracy in diagnosis and prognosis. The purpose of this study is to evaluate the efficacy of the combination of liver and spleen stiffness in the diagnosis of PSVD and to search for effective biomarkers for the diagnosis of PSVD through a single-center, prospective, observational study.', 'detailedDescription': 'PSVD is a supplement to non-cirrhotic portal hypertension and is defined as a class of diseases with characteristic pathological changes based on portal vein or hepatic sinuses abnormalities without cirrhosis. Some patients treated with platinum-based chemotherapy drugs will develop PSVD, which is clinically manifested as portal hypertension related complications. The diagnosis of PSVD depends on liver biopsy. In addition, the level of portal vein pressure has guiding value in the diagnosis and prognosis of PSVD. However, liver biopsy and pressure measurement are invasive methods. Many studies have shown that liver and spleen stiffness have high accuracy in diagnosis and prognosis. The purpose of this study is to evaluate the efficacy of the combination of liver and spleen stiffness in the diagnosis of PSVD and to search for effective biomarkers for the diagnosis of PSVD through a single-center, prospective, observational study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients had organ tumors and had received platinum chemotherapy before, the expected survival time is not less than half of year.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Received platinum chemotherapy for organ tumors;\n2. Ages 18-80;\n3. sign the informed consent voluntarily.\n\nExclusion Criteria:\n\n1. Liver pathology suggested cirrhosis;\n2. Underwent liver transplantation;\n3. Combined with hepatocellular carcinoma exceeding Milan criteria;\n4. Complicated with severe heart, kidney, or lung failure;\n5. Pregnant or lactating women;\n6. Data is seriously missing;\n7. Patients were judged not suitable for participation in this study by the researchers.'}, 'identificationModule': {'nctId': 'NCT06500403', 'briefTitle': 'Non-invasive Tools for PSVD Diagnosis', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'Noninvasive Tools for the Diagnosis of Porto-sinusoidal Vascular Disease: a Single-center, Prospective, Cohort Study', 'orgStudyIdInfo': {'id': 'NFEC-2023-566'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who have received platinum-based chemotherapy for organ tumors', 'interventionNames': ['Diagnostic Test: liver and stiffness measurement']}], 'interventions': [{'name': 'liver and stiffness measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'liver and spleen stiffness measurement are non-invasive tools for evaluation of cirrhosis and portal hypertension', 'armGroupLabels': ['Patients who have received platinum-based chemotherapy for organ tumors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaofeng Zhang', 'role': 'CONTACT', 'email': '1282614092@qq.com', 'phone': '+8618565552050'}], 'facility': 'Nanfang hospital, Southern Medical Uiversity', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xiaofeng Zhang', 'role': 'CONTACT', 'email': '1282614092@qq.com', 'phone': '+8618565552050'}], 'overallOfficials': [{'name': 'Xiaofeng Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}