Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-31 @ 5:29 PM
Study NCT ID:
NCT05600634
Status:
RECRUITING
Last Update Posted:
2023-11-28
First Post:
2022-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi Center Observation of Sentinel Skin Graft for Detecting Acute Rejection After Renal Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2022-10-27', 'studyFirstSubmitQcDate': '2022-10-27', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2017 Banff Kidney Transplantation Rejection Rating', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'A rating evaluation on kidney rejection'}, {'measure': '2007-edition Banff skin containing allogeneic composite histopathological diagnosis grading', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Skin histopathological diagnosis'}, {'measure': 'Renal function testing', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Blood Cr and Bun testing'}], 'secondaryOutcomes': [{'measure': 'Renal ultrasound diagnosis', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Renal ultrasound diagnosis'}, {'measure': 'Complications', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Complications assessment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Transplant Rejection', 'Skin Graft']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to explore the accuracy of sentinel skin grafts from the same donor source in diagnosing renal allograft rejection, and to provide new ideas and options for the later clinical diagnosis of renal allograft rejection. Further, try to provide timing guidance for early immunization intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study is an exploratory study. In the early stage, there is no relevant study on the accuracy of sentinel skin flap monitoring renal rejection, and there is a lack of corresponding sensitivity and specificity indicators. Considering that the incidence of acute rejection in the first year after transplantation is 15-30%, it is estimated that 20 cases will be included. Because the experimental data may be lost, or the participants may withdraw from the trial or lose the interview, the sample size will be increased by 20%, and finally 24 cases will be included in the trial.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with end-stage renal disease undergoing renal transplantation;\n2. 18-60 years old;\n3. Postoperative follow-up points are complete (visit the hospital every week in the first month after surgery, every two weeks in 2-3 months, every four to six months, and every three months in 7-12 months. Follow up at any time when skin rejection is observed. The follow-up time may be adjusted when the condition changes);\n4. The participants had good compliance, volunteered to participate in the test and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Untreated or disseminated malignant tumor;\n2. Active period of infectious diseases;\n3. Serious cardiovascular disease occurred recently;\n4. Combined with other important organ failure;\n5. History of mental illness or cognitive impairment;'}, 'identificationModule': {'nctId': 'NCT05600634', 'briefTitle': 'Multi Center Observation of Sentinel Skin Graft for Detecting Acute Rejection After Renal Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Multi Center Clinical Observation of Sentinel Skin Graft From the Same Donor Source for Detecting Acute Rejection After Renal Transplantation', 'orgStudyIdInfo': {'id': '2023-0719'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Kidney and skin transplataiton', 'interventionNames': ['Procedure: Skin allotransplantation']}], 'interventions': [{'name': 'Skin allotransplantation', 'type': 'PROCEDURE', 'description': 'Sentinel skin grafts from the same donor source will be carried on in the meantime of kidney transplantation for assisting to detect acute renal rejection.', 'armGroupLabels': ['Kidney and skin transplataiton']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400041', 'city': "Xi'an", 'state': 'Shannxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Geng Zhang, M.D.', 'role': 'CONTACT'}], 'facility': 'Xijing Hospital, Ari Force Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinghong Xu, M.D.', 'role': 'CONTACT'}], 'facility': 'First Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weiqiang Tan, M.D.', 'role': 'CONTACT', 'email': 'tanweixxxx@163.com', 'phone': '+8613666658609'}], 'facility': 'Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Chenggang Yi, M.D.', 'role': 'CONTACT', 'email': 'cwar@163.com', 'phone': '+8613567113534'}, {'name': 'Songxue Guo, M.D.', 'role': 'CONTACT', 'email': 'guosongxue@zju.edu.cn', 'phone': '+8618506857388'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zhejiang University', 'class': 'OTHER'}, {'name': 'Sir Run Run Shaw Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Air Force Medicial University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}