Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2025-12-24 @ 5:42 PM
Study NCT ID:
NCT04525768
Status:
UNKNOWN
Last Update Posted:
2020-08-25
First Post:
2020-08-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gastroesophageal Varices in Cavernoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-23', 'studyFirstSubmitDate': '2020-08-20', 'studyFirstSubmitQcDate': '2020-08-23', 'lastUpdatePostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'History of variceal bleeding', 'timeFrame': '1 day (the same time as diagnosis)', 'description': 'Have a history of the occurrence of gastroesophageal variceal bleeding'}], 'secondaryOutcomes': [{'measure': '1-year death rate', 'timeFrame': '1 year', 'description': '1-year death rate'}, {'measure': 'Complications of portal hypertension', 'timeFrame': '1 year', 'description': 'The concurrence of complications of portal hypertension (ascites, infections, variceal bleeding, et al)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['portal hypertension', 'gastroesophageal varices', 'jak2 mutation', 'myeloproliferative Neoplasm', 'portal caver cavernoma'], 'conditions': ['Gastroesophageal Varices', 'Myeloproliferative Neoplasm', 'Portal Caver Cavernoma', 'Portal Hypertension']}, 'referencesModule': {'references': [{'pmid': '28543980', 'type': 'RESULT', 'citation': 'Reilly CR, Babushok DV, Martin K, Spivak JL, Streiff M, Bahirwani R, Mondschein J, Stein B, Moliterno A, Hexner EO. Multicenter analysis of the use of transjugular intrahepatic portosystemic shunt for management of MPN-associated portal hypertension. Am J Hematol. 2017 Sep;92(9):909-914. doi: 10.1002/ajh.24798. Epub 2017 Jul 26.'}, {'pmid': '25027569', 'type': 'RESULT', 'citation': 'Yan M, Geyer H, Mesa R, Atallah E, Callum J, Bartoszko J, Yee K, Maganti M, Wong F, Gupta V. Clinical features of patients with Philadelphia-negative myeloproliferative neoplasms complicated by portal hypertension. Clin Lymphoma Myeloma Leuk. 2015 Jan;15(1):e1-5. doi: 10.1016/j.clml.2014.04.004. Epub 2014 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'Myeloproliferative neoplasms (MPNs), including polycythemia vera, essential thrombocythemia, and primary myelofibrosis, may lead to gastroesophageal varices. The quality of life, morbidity, and mortality of MPN patients mainly depend on disease-related symptoms, thromboembolic and hemorrhagic complications. Previous studies have shown that JAK2 V617F has a prominent role in vascular risk and MPN-associated gastroesophageal varices. Portal vein thrombosis and portal cavernoma frequently occur in the MPN population and the management of gastroesophageal varices in these patients are sometimes technically difficult. The aim of this study is to investigate the the characteristics of patients with gastroesophageal varices and portal caver cavernoma with or without JAK2 mutation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who diagnosed with portal cavernoma and gastric and/or esophageal varices and underwent JAK2 mutation test.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female patients aged 18-75\n* diagnosed as portal hypertension and portal cavernoma by contrast-enhanced computed tomography\n* underwent JAK2 mutation test\n\nExclusion Criteria:\n\n* combined known etiologies of chronic liver disease, including hepatitis, primary biliary cirrhosis, schistosomiasis, and non-alcoholic fatty liver disease.\n* other factors judged by the investigator that may affect the safety of the subject or the compliance of the trial. Such as serious illnesses (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors.'}, 'identificationModule': {'nctId': 'NCT04525768', 'briefTitle': 'Gastroesophageal Varices in Cavernoma', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Characteristic of Patients With Gastroesophageal Varices and Portal Cavernoma', 'orgStudyIdInfo': {'id': 'ZS-cavernoma-EGV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'JAK2 mutation Group', 'description': 'Patients with portal caver cavernoma and gastroesophageal varices and JAK2 Mutation.', 'interventionNames': ['Diagnostic Test: JAK2 mutation test']}, {'label': 'Portal caver cavernoma Group', 'description': 'Patients with portal caver cavernoma and gastroesophageal varices without JAK2 Mutation.', 'interventionNames': ['Diagnostic Test: JAK2 mutation test']}], 'interventions': [{'name': 'JAK2 mutation test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients with portal caver cavernoma will be divided into two groups by the result of JAK2 mutation test', 'armGroupLabels': ['JAK2 mutation Group', 'Portal caver cavernoma Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Xiaoquan HUANG, M.D.', 'role': 'CONTACT', 'email': 'huangxiaoquan1010@aliyun.com', 'phone': '+86-18801733835'}], 'facility': '180 Fenglin Road', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'XiaoquanHUANG', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}