Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
Study NCT ID:
NCT04527666
Status:
UNKNOWN
Last Update Posted:
2020-08-27
First Post:
2020-08-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anticoagulation in Gastroesophageal Varices and JAK2 Mutation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000925', 'term': 'Anticoagulants'}], 'ancestors': [{'id': 'D006401', 'term': 'Hematologic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, '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': '2020-08-25', 'studyFirstSubmitDate': '2020-08-23', 'studyFirstSubmitQcDate': '2020-08-23', 'lastUpdatePostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of portal vein thrombosis', 'timeFrame': '1 year', 'description': 'The changes of portal vein thrombosis including progression, disappear or unchanged.'}], 'secondaryOutcomes': [{'measure': 'The occurrence of variceal bleeding', 'timeFrame': '1 year', 'description': 'The occurrence of variceal bleeding including haematemesis and melena'}, {'measure': 'Overall survival', 'timeFrame': '1 year', 'description': 'Overall survival rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['portal hypertension', 'gastroesophageal varices', 'jak2 mutation', 'myeloproliferative neoplasm'], 'conditions': ['Gastroesophageal Varices', 'JAK2 Mutation', 'Myeloproliferative Neoplasm']}, 'referencesModule': {'references': [{'pmid': '30574023', 'type': 'BACKGROUND', 'citation': 'Greenfield G, McMullin MF. Splanchnic venous thrombosis in JAK2 V617F mutation positive myeloproliferative neoplasms - long term follow-up of a regional case series. Thromb J. 2018 Dec 19;16:33. doi: 10.1186/s12959-018-0187-z. eCollection 2018.'}, {'pmid': '25027569', 'type': 'BACKGROUND', '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.'}, {'pmid': '32679300', 'type': 'BACKGROUND', 'citation': 'Magaz M, Alvarez-Larran A, Colomer D, Lopez-Guerra M, Garcia-Criado MA, Mezzano G, Belmonte E, Olivas P, Soy G, Cervantes F, Darnell A, Ferrusquia-Acosta J, Baiges A, Turon F, Hernandez-Gea V, Garcia-Pagan JC. Next-generation sequencing in the diagnosis of non-cirrhotic splanchnic vein thrombosis. J Hepatol. 2021 Jan;74(1):89-95. doi: 10.1016/j.jhep.2020.06.045. Epub 2020 Jul 15.'}, {'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.'}]}, '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. The aim of this study is to evaluate the efficacy of anticoagulation in patients with JAK2 mutation and gastroesophageal varices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with gastric and/or esophageal varices and JAK2 mutation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients aged 18-75\n* diagnosed as portal hypertension by contrast-enhanced computed tomography\n* diagnosed as JAK2 positive\n\nExclusion Criteria:\n\n* not had portal contrast-enhanced computed tomography\n* not had JAK2 mutation test\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': 'NCT04527666', 'briefTitle': 'Anticoagulation in Gastroesophageal Varices and JAK2 Mutation', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Anticoagulation Treatment of Patients With Gastroesophageal Varices and JAK2 V617 Mutation', 'orgStudyIdInfo': {'id': 'ZS-ANTICO-JAK2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anticoagulation group', 'description': 'Patients with JAK2 mutation and gastroesophageal varices receive anticoagulation agents.', 'interventionNames': ['Drug: Anticoagulation Agents']}, {'label': 'Control group', 'description': "Patients with JAK2 mutation and gastroesophageal varices who didn't receive anticoagulation agents."}], 'interventions': [{'name': 'Anticoagulation Agents', 'type': 'DRUG', 'description': 'Patients receive anticoagulation agents including low molecular weight heparin, warfarin, rivaroxaban, et al.', 'armGroupLabels': ['Anticoagulation group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xiaoquan HUANG, Ph.D', 'role': 'CONTACT', 'email': 'huang.xiaoquan@zs-hospital.sh.cn', 'phone': '18801733835'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'XiaoquanHUANG', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}