Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT00215033
Status:
TERMINATED
Last Update Posted:
2012-03-16
First Post:
2005-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relationship Between EBV and PTLD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'whyStopped': 'sufficient data gathered to support conclusion', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-14', 'studyFirstSubmitDate': '2005-09-20', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epstein-Barr virus', 'pediatric health', 'cardiac', 'heart transplant', 'lymphoproliferative disease', 'post-transplant', 'pediatric transplant'], 'conditions': ['Pediatric Heart Transplant']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the significance of an elevated quantitative EBV PCR and to determine the relationship between a EBV PCR value and the risk of developing PTLD.', 'detailedDescription': 'The relationship between Epstein-Barr virus and lymphoproliferative disease has been established, particularly in the immuno-suppressed patient. Over the past several years a quantitative EBV PCR lab test has been established. Unfortunately, the significance of an elevated test remains unclear. The relationship of a particular EBV PCR value and the risk of developing PTLD is unknown. The primary aims will be to determine the significance of an elevated quantitative EBV PCR and to determine the relationship between a EBV PCR value and the risk of developing PTLD. The study will be conducted through a retrospective chart review of approximately 160 patients and we will look at postoperative data including Quantitative EBV PCR results, the presence / absence of PTLD and the treatment of PTLD and results of EBV PCR with treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergone pediatric heart transplant', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergone pediatric heart transplant\n* followed by pediatric heart transplant program\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00215033', 'briefTitle': 'Relationship Between EBV and PTLD', 'organization': {'class': 'OTHER', 'fullName': "Children's Healthcare of Atlanta"}, 'officialTitle': 'Relationship Between Quantitative Epstein-Bar Viral(EBV) Titres and Post-Transplant Lymphoproliferative Disease', 'orgStudyIdInfo': {'id': '05-089'}}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Brian Kogon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Healthcare of Atlanta", 'class': 'OTHER'}}}}