Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT01816256
Status:
COMPLETED
Last Update Posted:
2023-07-21
First Post:
2013-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Screening for Asymptomatic Portal Vein Thrombosis and Portal Hypertension in Patients With Philadelphia Negative Myeloproliferative Neoplasms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D011087', 'term': 'Polycythemia Vera'}, {'id': 'D013920', 'term': 'Thrombocythemia, Essential'}, {'id': 'D055728', 'term': 'Primary Myelofibrosis'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D019046', 'term': 'Bone Marrow Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D013922', 'term': 'Thrombocytosis'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016145', 'term': 'Endoscopy, Digestive System'}], 'ancestors': [{'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2013-01-14', 'studyFirstSubmitQcDate': '2013-03-19', 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Identify any genetic markers or biomarkers associated with asymptomatic PVT and PHTN', 'timeFrame': '6 years'}], 'primaryOutcomes': [{'measure': 'Incidence of asymptomatic portal vein thrombosis (PVT) and/or portal hypertension (PHTN) in patients with Philadelphia negative myeloproliferative neoplasms (MPNs)', 'timeFrame': '6 years'}], 'secondaryOutcomes': [{'measure': 'Identify the patient, disease and treatment related risk factors associated with PVT and PHTN', 'timeFrame': '6 years'}, {'measure': 'Comparison of survival and number of patients with leukemic transformation in patients with or without asymptomatic PVT/PHTN', 'timeFrame': '8 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myeloproliferative Neoplasms (MPN)', 'Polycythemia Vera (PV)', 'Essential Thrombocythemia (ET)', 'Myelofibrosis (MF)']}, 'descriptionModule': {'briefSummary': 'This study involves screening for portal vein thrombosis and portal hypertension in patients with Philadelphia negative myeloproliferative neoplasms (MPNs). These include polycythemia vera (PV), essential thrombocythemia (ET), and myelofibrosis.\n\nPortal vein thrombosis and portal hypertension are serious complications that are often seen in myeloproliferative patients. These complications are usually diagnosed when patients become symptomatic, and are often already at an advanced stage. They can further progress to cause non-reversible damage to the liver, also called cirrhosis of the liver. As a result of this, patients often accumulate fluid in the abdomen which is ascites; and can develop swelling of veins in the lining of the esophagus known as varices. If untreated, varices have the risk of rupturing resulting in life-threatening bleeding. When diagnosed at an advanced stage, the treatment is usually supportive therapy and there are no treatments available at present which can reverse these conditions.\n\nThis study is looking at screening for these two conditions using Doppler ultrasound and upper gastrointestinal endoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* One of the three classical Philadelphia negative myeloproliferative neoplasms (polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF)) diagnosed according to WHO or International working group-Myelofibrosis research and treatment (IWG-MRT) criteria\n* Palpable spleen length greater than 5 cm below the costal margin in MF (including primary MF or post-polycythemia vera MF (PPV-MF) post-polycythemia vera ET (PPV-ET)) or palpable spleen of any size in patients with PV or ET.\n* Ability to understand and willing to sign a written consent form.\n* Age 18 years or older at time of consent.\n\nExclusion criteria:\n\n* Known history of portal vein thrombosis\n* Known history of Budd-chairi syndrome\n* Known history of oesophageal varices\n* Known history of cirrhosis from any cause\n* Known history of active bleeding'}, 'identificationModule': {'nctId': 'NCT01816256', 'briefTitle': 'Screening for Asymptomatic Portal Vein Thrombosis and Portal Hypertension in Patients With Philadelphia Negative Myeloproliferative Neoplasms', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Screening for Asymptomatic Portal Vein Thrombosis and Portal Hypertension in Patients With Philadelphia Negative Myeloproliferative Neoplasms', 'orgStudyIdInfo': {'id': 'MPN 12-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Screening tests', 'description': 'This is a one arm study. All patients will receive two screening tests (Doppler ultrasound, upper gastrointestinal endoscopy).', 'interventionNames': ['Procedure: Upper gastrointestinal endoscopy and Doppler ultrasound']}], 'interventions': [{'name': 'Upper gastrointestinal endoscopy and Doppler ultrasound', 'type': 'PROCEDURE', 'description': 'This is a one arm study. All patients will receive two screening tests (Doppler ultrasound, upper gastrointestinal endoscopy).', 'armGroupLabels': ['Screening tests']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Vikas Gupta, MD, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Princess Margaret Cancer Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}