Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-02 @ 12:28 AM
Study NCT ID:
NCT01983059
Status:
UNKNOWN
Last Update Posted:
2023-03-15
First Post:
2013-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Swiss Liver Venous Thrombosis Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood, serum, plasma, stool and urine samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-14', 'studyFirstSubmitDate': '2013-11-06', 'studyFirstSubmitQcDate': '2013-11-12', 'lastUpdatePostDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with liver venous thrombosis recanalization', 'timeFrame': 'End of study, expected to be on average after 5 years'}], 'secondaryOutcomes': [{'measure': 'Number of patient with thrombosis recurrence and progression', 'timeFrame': 'End of study, expected to be on average after 5 years'}, {'measure': 'Overall mortality', 'timeFrame': 'End of study, expected to be on average after 5 years'}, {'measure': 'Number of patients with major bleeding', 'timeFrame': 'End of study, expected to be on average after 5 years'}, {'measure': 'Number of patients with ascites', 'timeFrame': 'End of study, expected to be on average after 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Observational Study']}, 'descriptionModule': {'briefSummary': 'The Liver Venous Thrombosis Study is a prospective observational cohort study aimed at collecting clinical data, patient reported outcomes and biological samples of all patients who have been newly and previously diagnosed with liver venous thrombosis in one of the participating hospitals in- and out-patient clinics of the participating centers in Switzerland. All new patients diagnosed with liver venous thrombosis or patients who are currently being treated in one of the participating centers, will be asked to participate in the study.', 'detailedDescription': 'Background\n\nOutcome measures:\n\nPrimary: Liver venous thrombosis recanalization\n\nSecondary: Thrombosis progression, Overall mortality, Major bleeding, Ascites\n\nObjective\n\n* To start a prospective observational cohort study of Liver Venous Thrombosis patients in Switzerland from their primary diagnosis and already diagnosed patients.\n* To examine long-term medical outcomes in patients with liver venous thrombosis in Switzerland by defining incidence, risk factors and treatment results\n* To prospectively collect data on medical history, serious comorbidities, baseline clinical parameters, imaging results, pathology results, tumor characteristics, treatment, treatment outcomes, hospital stays, interventions and complications.\n* To store in a biobank blood and biological samples, obtained during routine practice\n\nMethods\n\nN/A'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All Liver Venous Thrombosis patients in participating hospitals in Switzerland', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Admitted in hospital or attend outpatient clinic\n* Objectively confirmed portal vein thrombosis and/or hepatic vein thrombosis\n* Budd-Chiari-Syndrome (BCS), Non-Cirrhotic Intrahepatic Portal Hypertension (NCIPH), Sinusoidal Obstructive Syndrome (SOS), Other Vascular Diseases (Hepatoportal Sclerosis (HC), Nodular Regenerative Hyperplasia (NRH), Obliterative Portal Venopathy (OPV) or Idiopathic Portal Hypertension (IPH))\n* Subjects willing to provide informed consent\n\nExclusion Criteria\n\n* Thrombosis limited to mesenteric or splenic vein\n* Inability to sign consent form\n* Follow-up not possible\n* Cardiovascular, tumoral, pulmonary comorbidity with life expectancy estimated to be less than 6 months\n* Portal vein invasion by hepatocellular carcinoma'}, 'identificationModule': {'nctId': 'NCT01983059', 'acronym': 'SLVTS-SASL-35', 'briefTitle': 'Swiss Liver Venous Thrombosis Study', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'A Multicenter Prospective Observational Cohort Study', 'orgStudyIdInfo': {'id': 'SLVTS-SASL-35'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Liver Venous Thrombosis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'state': 'Canton of Bern', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'Department of Clinical Research, Hepatology Research Group', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '4031', 'city': 'Basel', 'state': 'Kanton Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'Klinik für Gastroenterologie und Hepatologie, Universtätsspital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '5404', 'city': 'Baden', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'Medizinische Klinik - Kantonsspital Baden', 'geoPoint': {'lat': 47.47333, 'lon': 8.30592}}, {'zip': '1211', 'city': 'Geneva', 'status': 'NOT_YET_RECRUITING', 'country': 'Switzerland', 'facility': 'Service de Gastro-entérologie et Hépatologie, Hôpitaux Universtaires de Genève', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': '1011', 'city': 'Lausanne', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': "Service de Gastroentérologie et d'Hépatologie, Centre Hospitalier Universitaire Vaudois", 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'zip': '6900', 'city': 'Lugano', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'Centro di Epatologia - Clinica Luganese Moncucco', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}, {'zip': '9007', 'city': 'Sankt Gallen', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'Klinik für Gastroenterologie/Hepatologie, Kantonsspital St. Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': '8091', 'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'Klinik für Gastroenterologie und Hepatologie Universitätsspital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Andrea De Gottardi, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'andrea.degottardi@insel.ch', 'phone': '031 632 38 13'}], 'overallOfficials': [{'name': 'Andrea De Gottardi, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inselspital (University Hospital) Bern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'Foundation for Liver Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}