Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-28 @ 6:22 PM
Study NCT ID:
NCT04660266
Status:
UNKNOWN
Last Update Posted:
2020-12-09
First Post:
2020-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of Ultrasound Exam, Including Doppler and Elastography, in the Diagnosis of VOD, Following Bone Marrow Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'liver evaluation by US before, 14 days and 21 days after bone marrow transplantation, in the purpose to predict the appearance of Veno occlusive disease.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-06', 'studyFirstSubmitDate': '2020-11-18', 'studyFirstSubmitQcDate': '2020-12-06', 'lastUpdatePostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of liver ultrasound in predicting VOD', 'timeFrame': '21 days', 'description': 'ultrasound results inculding gray scale , doppler and elastography will be compared to the clinical diagnosis of VOD the diagnosis of VOD will be performed according to the Europian Society for Blood and Marrow transplantation revised criteria\n\n1. presence of ascites yes/no\n2. liver enlagement more than 17 cm\n3. Bilirubin \\>2 mg/dl'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['VOD', 'Ultrasound Therapy; Complications']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/6363247/', 'label': 'Related Info'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/19766729/', 'label': 'Related Info'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/17768390/', 'label': 'Related Info'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/8420443/', 'label': 'Related Info'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/3321587/', 'label': 'Related Info'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/27183098/', 'label': 'Related Info'}, {'url': 'https://europepmc.org/article/med/30895833', 'label': 'Related Info'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/9240551/', 'label': 'Related Info'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/29767845/', 'label': 'Related Info'}, {'url': 'https://www.x-mol.com/paper/1276245089442099200', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study:\n\nValidation of the use of intentional ultrasound examination, which includes Doppler and elastography for the diagnosis of obstructive venous disease of the liver within 21 days after bone marrow transplantation.\n\nProtocol:\n\nPatients who are planned for a bone marrow transplantaion will be recruited for the study by the staff of the Transplant Department. Inclusion criteria: Patients over the age of 18 before a bone marrow transplantation.\n\nEligibility criteria: Transplanted under 18 years of age\n\nResearch protocol:\n\nAfter informed consent, patients will undergo an ultrasound examination before the transplant.\n\nAfter 14 days and again after 21 days patients will undergo two more US exams, If there is a change in their clinical condition the patients will undergo additional examination accordingly.\n\nAt the same time on the 14th and 21st day a clinical evaluation will be performed by the clinical physician in the transplant department based on clinical criteria of European Blood and Brain Transplant Association (EBMT).\n\nThe results of the clinical evaluation and blood test results will be collected.\n\nPatients will be divided into two groups:\n\n* Control group: Patients who did not develop VOD( veno occlusive disease ) during 21 days.\n* Study group: Patients who developed VOD during 21 days.\n\nAll ultrasound examination data will be compared between the two groups in\n\nIn addition will be collected:\n\n* Demographics - age, sex.\n* Background diseases including heart and liver diseases.\n* Basic disease as a transplantation cause.\n\nAll data will be collected anonymously and coded separately.', 'detailedDescription': 'The purpose of the study:\n\nValidation of the use of intentional ultrasound examination, which includes Doppler and elastography for the diagnosis of obstructive venous disease of the liver within 21 days after bone marrow transplantation.\n\nProtocol:\n\nPatients who are planned for a bone marrow transplantaion will be recruited for the study by the staff of the Transplant Department. Inclusion criteria: Patients over the age of 18 before a bone marrow transplantation.\n\nEligibility criteria: Transplanted under 18 years of age\n\nResearch protocol:\n\nAfter informed consent, patients will undergo an ultrasound examination before the transplant.\n\nThe test will include:\n\n1. Demonstration of liver including its size.\n2. Gallbladder demonstration including its width and wall thickness.\n3. Main portal vein width, Speed and flow direction in main portal vein.\n4. Evaluation of umbilical vein in the falciform ligament to check existence of flow and venous width in case it opened.\n5. Assessment of existence a small / medium or large amount of ascites measurement of resistance index in the main hepatic artery.\n6. Complete elastography examination.\n\nAfter 14 days and again after 21 days patients will undergo two more US exams, If there is a change in their clinical condition the patients will undergo additional examination accordingly.\n\nAt the same time on the 14th and 21st day a clinical evaluation will be performed by the clinical physician in the transplant department based on clinical criteria of European Blood and Brain Transplant Association (EBMT).\n\nThe results of the clinical evaluation and blood test results will be collected.\n\nPatients will be divided into two groups:\n\n* Control group: Patients who did not develop VOD( veno occlusive disease ) during 21 days.\n* Study group: Patients who developed VOD during 21 days.\n\nAll ultrasound examination data will be compared between the two groups in\n\nIn addition will be collected:\n\n* Demographics - age, sex.\n* Background diseases including heart and liver diseases.\n* Basic disease as a transplantation cause.\n\nAll data will be collected anonymously and coded separately.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over the age of 18 before a bone marrow transplantation.\n\nExclusion Criteria:\n\n* Transplanted under 18 years of age.'}, 'identificationModule': {'nctId': 'NCT04660266', 'briefTitle': 'Accuracy of Ultrasound Exam, Including Doppler and Elastography, in the Diagnosis of VOD, Following Bone Marrow Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Accuracy of Ultrasound Exam, Including Doppler and Elastography, in the Diagnosis of VOD, in the 21 Days Following Bone Marrow Transplantation', 'orgStudyIdInfo': {'id': '0696-20-RMB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'all cohort', 'interventionNames': ['Diagnostic Test: Liver Ultrasound']}], 'interventions': [{'name': 'Liver Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'liver ultrasound examination, including gray-scale and seven Doppler examination', 'armGroupLabels': ['all cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'state': 'Israek', 'country': 'Israel', 'contacts': [{'name': 'NIRA BECK-RAZI, md', 'role': 'CONTACT', 'email': 'n_beck_razi@rambam.health.gov.il', 'phone': '97247772664'}], 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Nira Beck Razi, MD', 'role': 'CONTACT', 'email': 'n_beck_razi@mbam.health.gov.il', 'phone': '972502061204'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}