Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-01-18 @ 12:22 PM
Study NCT ID:
NCT02798861
Status:
COMPLETED
Last Update Posted:
2020-07-31
First Post:
2016-06-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Controlled Attenuation Parameter (CAP) in Liver Allografts
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'duarterojoa@pitt.edu', 'phone': '412-647-7922', 'title': 'Andres Duarte-Rojo', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'No adverse event data were collected because the study was observational.', 'description': 'No adverse event data were collected because the study was observational.', 'eventGroups': [{'id': 'EG000', 'title': 'CAP Assessment', 'description': 'Controlled Attenuation Parameter with Fibroscan 402/530 before liver procurement and after liver transplantation to assess steatosis, and its association with clinical outcomes\n\nFibroscan 402/530: Fibroscan 402/530 obtained before procurement in the donor and at 1 to 6 months post-transplant in the liver recipient.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Controlled Attenuation Parameter (CAP) - Accuracy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAP Assessment', 'description': 'Controlled Attenuation Parameter with Fibroscan 402/530 before liver procurement and after liver transplantation to assess steatosis, and its association with clinical outcomes\n\nFibroscan 402/530: Fibroscan 402/530 obtained before procurement in the donor and at 1 to 6 months post-transplant in the liver recipient.'}], 'classes': [{'categories': [{'measurements': [{'value': '220', 'groupId': 'OG000', 'lowerLimit': '176', 'upperLimit': '262'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (pre-procurement) to 6 months post liver transplant', 'description': 'CAP accuracy in quantification of liver steatosis to be determined using liver biopsies as reference', 'unitOfMeasure': 'dB/m', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Here are considered the allografts that were transplanted and whose recipients consented to participate in study'}, {'type': 'SECONDARY', 'title': 'LSM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAP Assessment', 'description': 'Controlled Attenuation Parameter with Fibroscan 402/530 before liver procurement and after liver transplantation to assess steatosis, and its association with clinical outcomes\n\nFibroscan 402/530: Fibroscan 402/530 obtained before procurement in the donor and at 1 to 6 months post-transplant in the liver recipient.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '8.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pretransplant to 6 months posttransplant', 'description': 'Liver stiffness measurement', 'unitOfMeasure': 'kPa', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Here are considered the allografts that were transplanted and whose recipients consented to participate in study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Allografts', 'description': 'Livers assessed before procurement and after implantation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CAP Assessment', 'description': 'Controlled Attenuation Parameter with Fibroscan 402/530 before liver procurement and after liver transplantation to assess steatosis, and its association with clinical outcomes\n\nFibroscan 402/530: Fibroscan 402/530 obtained before procurement in the donor and at 1 to 3 months post-transplant in the liver recipient.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37', 'spread': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '94', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'White', 'measurements': [{'value': '116', 'groupId': 'BG000'}]}, {'title': 'Black', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Hispanic', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '160', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'ALT', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '90'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'IU/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'AST', 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000', 'lowerLimit': '43', 'upperLimit': '195'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'IU/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '27', 'spread': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CAP', 'classes': [{'categories': [{'measurements': [{'value': '235', 'groupId': 'BG000', 'lowerLimit': '188', 'upperLimit': '274'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'dB/m', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'LSM', 'classes': [{'categories': [{'measurements': [{'value': '7.25', 'groupId': 'BG000', 'lowerLimit': '5.7', 'upperLimit': '10.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kPa', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-16', 'size': 295528, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-06-02T10:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2016-06-02', 'resultsFirstSubmitDate': '2020-06-02', 'studyFirstSubmitQcDate': '2016-06-08', 'lastUpdatePostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-15', 'studyFirstPostDateStruct': {'date': '2016-06-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Controlled Attenuation Parameter (CAP) - Accuracy', 'timeFrame': 'Baseline (pre-procurement) to 6 months post liver transplant', 'description': 'CAP accuracy in quantification of liver steatosis to be determined using liver biopsies as reference'}], 'secondaryOutcomes': [{'measure': 'LSM', 'timeFrame': 'Pretransplant to 6 months posttransplant', 'description': 'Liver stiffness measurement'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Liver Transplant', 'Liver Steatosis', 'Liver Disease', 'Primary Non-function', 'Early Allograft Dysfunction']}, 'descriptionModule': {'briefSummary': 'The primary aim is to determine the accuracy of CAP in the quantification of liver steatosis using liver biopsies as reference. Secondarily, investigators will correlate transient elastography (TE) and CAP results, analyze possible associations between CAP/TE and post-liver transplant (LT) clinical outcomes, and evaluate the change in CAP after LT. The study aims to include as many donors as needed to achieve at least 120 transplanted liver allografts.', 'detailedDescription': 'This is a coordinated study utilizing 3 recruitment centers (University of Arkansas for Medical Sciences \\[UAMS\\], Stanford University, and Mayo Clinic) 2 liver pathology reading centers (University of Michigan and Mayo Clinic), and 1 coordinating center (University of Arkansas). The cohort study with a cross-sectional component for the primary aim has been completed (through independent Institutional Review Board \\[IRB\\] agreements) at UAMS, Stanford University, and the Mayo Clinic. The samples collected at the three recruitment centers will be sent to the biopsy center at the University of Michigan and Mayo Clinic for evaluation. The Liver Transplant Program at each of the 3 recruiting centers will identify study subjects during the process of liver allocation to their listed recipients. Criteria for recruitment are as follows:\n\nInclusion criteria - Liver Recipient\n\n* Men and women, Age 18-years old to 80-years old inclusive Inclusion criteria - Liver Donor\n* Valid TE with Fibroscan 530, defined as:\n\n * At least 10 valid measurements\n * Interquartile Range (IQR)/Median stiffness value \\<30% (only in cases with \\>7.1 kPa) Exclusion criteria - Liver Recipient\n* Patient did not undergo liver transplantation Exclusion criteria - Liver Donor\n* Donation after circulatory death (DCD)\n* No liver biopsy obtained during organ procurement process'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Allograft procured and transplanted into recipients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria - Liver Recipient\n\n* Men and women, Age 18-years old to 80-years old inclusive\n\nInclusion criteria - Liver Donor\n\n* Valid TE with Fibroscan 402/530, defined as:\n\n * At least 10 valid measurements\n * IQR/Median stiffness value \\<30% (only in cases with \\>7.1 kPa)\n\nExclusion criteria - Liver Recipient\n\n* Patient did not undergo liver transplantation\n\nExclusion criteria - Liver Donor\n\n* Donation after circulatory death (DCD)\n* No liver biopsy obtained during organ procurement process'}, 'identificationModule': {'nctId': 'NCT02798861', 'briefTitle': 'Controlled Attenuation Parameter (CAP) in Liver Allografts', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Usefulness of Controlled Attenuation Parameter (CAP) for the Assessment of Liver Steatosis in Liver Donors', 'orgStudyIdInfo': {'id': '204560'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CAP assessment', 'description': 'Controlled Attenuation Parameter with Fibroscan 402/530 before liver procurement and after liver transplantation to assess steatosis, and its association with clinical outcomes', 'interventionNames': ['Device: Fibroscan 402/530']}], 'interventions': [{'name': 'Fibroscan 402/530', 'type': 'DEVICE', 'description': 'Fibroscan 402/530 obtained before procurement in the donor and at 1 to 3 months post-transplant in the liver recipient.', 'armGroupLabels': ['CAP assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Andres Duarte-Rojo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Andres Duarte-Rojo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Andres Duarte-Rojo', 'investigatorAffiliation': 'University of Pittsburgh'}}}}