Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-05 @ 1:06 AM
Study NCT ID:
NCT03183258
Status:
UNKNOWN
Last Update Posted:
2019-04-17
First Post:
2017-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vascularised Sentinel Skin Flaps to Detect Rejection in Pancreas Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2017-06-05', 'studyFirstSubmitQcDate': '2017-06-07', 'lastUpdatePostDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concordant allograft rejection', 'timeFrame': '12 months', 'description': 'If there is any clinical suspicion of rejection then both the sentinel skin flap and visceral allograft will be biopsied. Concordant rejection will be recorded where rejection is confirmed in both the sentinel skin flap and the visceral allograft.'}], 'secondaryOutcomes': [{'measure': 'Discordant rejection of the sentinel skin', 'timeFrame': '12 months', 'description': 'If there is any clinical suspicion of rejection then both the sentinel skin flap and visceral allograft will be biopsied. Discordant rejection will be recorded where there is rejection of the sentinel skin without rejection of the visceral allograft.'}, {'measure': 'Discordant rejection of the visceral allograft', 'timeFrame': '12 months', 'description': 'If there is any clinical suspicion of rejection then both the sentinel skin flap and visceral allograft will be biopsied. Discordant rejection will be recorded where there is rejection of the visceral allograft without rejection of the sentinel skin.'}, {'measure': 'Donor specific antibodies', 'timeFrame': '12 months', 'description': 'Development of de novo donor specific antibodies'}, {'measure': 'Immunosuppression', 'timeFrame': '12 months', 'description': 'Total dose immunosuppression'}, {'measure': 'Graft survival', 'timeFrame': '12 months', 'description': 'Pancreas allograft survival'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreas Transplant Rejection']}, 'descriptionModule': {'briefSummary': 'This pilot study aims to validate the use of vascularised donor-derived sentinel skin flaps for diagnosing rejection in pancreas transplantation. The aim of the study is to investigate the use of sentinel skin flaps in clinical practice and assess whether rejection occurs concordantly or discordantly between the skin flap and the transplanted abdominal organs. If successful, sentinel skin may allow improved immune surveillance and thereby facilitate earlier treatment of rejection with subsequent improvements in allograft survival and patient morbidity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Recipient of a pancreas transplant (SPK or PTA)\n* Participant is willing and able to give informed consent for participation in the study\n* Male or Female, aged 18 years or above\n\nExclusion Criteria:\n\n* Patient does not have a patent ulna artery in either forearm\n* Recipient of an enterically drained PTA\n* Patient has received any investigational medical drug within 30 days of transplantation\n* Patient is not willing to return to Oxford for all clinical follow-up for 12 months\n* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the trial, or the participant's ability to participate in the study."}, 'identificationModule': {'nctId': 'NCT03183258', 'briefTitle': 'Vascularised Sentinel Skin Flaps to Detect Rejection in Pancreas Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Vascularised Sentinel Skin Flaps to Detect Rejection in Pancreas Transplantation', 'orgStudyIdInfo': {'id': '15/SW/0333'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sentinel Skin Flap', 'interventionNames': ['Other: Sentinel skin flap']}], 'interventions': [{'name': 'Sentinel skin flap', 'type': 'OTHER', 'description': 'Donor-derived vascularised composite allograft (sentinel skin flap)', 'armGroupLabels': ['Sentinel Skin Flap']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 7LE', 'city': 'Oxford', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'James CH Barnes', 'role': 'CONTACT', 'email': 'James.Barnes@nds.ox.ac.uk', 'phone': '+447717707384'}], 'facility': 'Oxford University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'centralContacts': [{'name': 'James CH Barnes', 'role': 'CONTACT', 'email': 'James.Barnes@nds.ox.ac.uk', 'phone': '+447717707384'}], 'overallOfficials': [{'name': 'Peter J Friend', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}