Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-04 @ 10:24 PM
Study NCT ID:
NCT02025335
Status:
COMPLETED
Last Update Posted:
2015-09-25
First Post:
2013-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Kidney Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-24', 'studyFirstSubmitDate': '2013-12-16', 'studyFirstSubmitQcDate': '2013-12-30', 'lastUpdatePostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CMV infection', 'timeFrame': '6 months after transplantation', 'description': 'CMV infection is defined as follows.\n\n1. CMV viremia: CMV antigenemia or CMV quantitative PCR (+)\n2. CMV disease: CMV syndrome or tissue-invasive CMV disease i) CMV syndrome: ① CMV viremia ② temperature \\> 38 without other cause ③ WBC \\< 4000, atypical lymphocyte \\> 3%, transaminase elevation, platelet \\< 100,000/mm ii) tissue-invasive CMV disease: evidence of CMV in histopathologic specimen (inclusion body or viral antigen in biopsy or bronchoalveolar lavage fluid)'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': '6 months after transplantation'}, {'measure': 'rejection', 'timeFrame': '6 months after transplantation'}, {'measure': 'graft loss', 'timeFrame': '6 months after transplantation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Kidney Transplantation Recipients']}, 'referencesModule': {'references': [{'pmid': '29865778', 'type': 'DERIVED', 'citation': 'Kim T, Lee HJ, Kim SM, Jung JH, Shin S, Kim YH, Sung H, Chong YP, Lee SO, Choi SH, Kim YS, Woo JH, Kim SH, Han DJ. Diagnostic usefulness of the cytomegalovirus (CMV)-specific T cell-based assay for predicting CMV infection after kidney transplant. Korean J Intern Med. 2020 Mar;35(2):438-448. doi: 10.3904/kjim.2017.318. Epub 2018 Jun 7.'}]}, 'descriptionModule': {'briefSummary': 'CMV is one of the most important opportunistic infection in transplant recipients. In South Korea, more than 95% of adults reveal sero-positivity for CMV IgG. Until now, sero-positivity for CMV IgG before solid organ transplantation is a laboratory test of choice to stratify the risk of CMV reactivation after solid organ transplantation. Theoretically, CMV-specific cell-mediate immune response before solid organ transplantation will further categorize the patients into high or low risk of CMV development after solid organ transplantation. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in kidney transplant candidates to predict the development of CMV infection after kidney transplantation.', 'detailedDescription': 'Between Mar 2014 and Mar 2015, all patients admitted in the kidney transplant unit will be enrolled in this study. All patients will receive CMV-specific ELISPOT assay and be prospectively followed for the development of CMV infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Kindeny transplant recipients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 16 or more\n* agree with written informed consent\n\nExclusion Criteria:\n\n* donor CMV IgG (+) and recipient CMV IgG (-)'}, 'identificationModule': {'nctId': 'NCT02025335', 'acronym': 'ACE-KT', 'briefTitle': 'Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Kidney Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Kidney Transplant Recipients (ACE-KT)', 'orgStudyIdInfo': {'id': '2013-1040'}, 'secondaryIdInfos': [{'id': '2013-1040'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'high CMV ELISPOT results', 'description': 'high spot counts in ELISPOT'}, {'label': 'low CMV ELISPOT results', 'description': 'low spot counts in ELISPOT'}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Sung-Han Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sung-Han Kim', 'investigatorAffiliation': 'Asan Medical Center'}}}}