Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT02060435
Status:
COMPLETED
Last Update Posted:
2014-02-12
First Post:
2014-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epstein-Barr Virus Status in Diffuse Large B Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'EBV RNA was detected by an in situ hybridization (ISH) technique using the EBV ISH kit (Leica Microsystems, Bannockburn, IL, USA).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 571}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-11', 'studyFirstSubmitDate': '2014-02-10', 'studyFirstSubmitQcDate': '2014-02-11', 'lastUpdatePostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'Two years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diffuse large B-cell lymphoma', 'Ebstein-Barr Virus'], 'conditions': ['Diffuse Large B-cell Lymphoma']}, 'referencesModule': {'references': [{'pmid': '25475080', 'type': 'DERIVED', 'citation': 'Hong JY, Yoon DH, Suh C, Huh J, Do IG, Sohn I, Jo J, Jung SH, Hong ME, Yoon H, Ko YH, Kim SJ, Kim WS. EBV-positive diffuse large B-cell lymphoma in young adults: is this a distinct disease entity? Ann Oncol. 2015 Mar;26(3):548-55. doi: 10.1093/annonc/mdu556. Epub 2014 Dec 4.'}]}, 'descriptionModule': {'briefSummary': 'The investigators analyzed clinical outcome in DLBCL patients according to age group to define the impact of EBV status on the clinical outcome.', 'detailedDescription': 'Epstein-Barr virus (EBV) positive diffuse large B-cell lymphoma (DLBCL) has been recognized as a new provisional entity in the 2008 World Health Organization (WHO) classification of tumors of hematopoietic and lymphoid tissue. This lymphoma is defined as EBV+ clonal B-cell proliferation in immunocompetent adults older than 50 years. To denote patient age in definition of this disease, age cutoff was defined as older than 50 years. However, this cutoff is clearly arbitrary without any scientific background. the knowledge on EBV+DLBCL in young adult is very scanty. This EBV+DLBCL in young adult can be the same disease entity or it can be a distinct disease form EBV+DLBCL of elderly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '17 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '(1) pathologically confirmed de novo DLBCL, according to the World Health Organization (WHO) classification: (ii) registered in Samsung Medical Center (SMC) Lymphoma Cohort Study I/II (ClinicalTrials.gov Identifier: NCT00822731, NCT01877109) or identified from Asan Medical Center (AMC) medical database: (iii) adequate amount and quality of paraffin-embedded biopsy specimen or unstained slides for EBV-encoded RNA (EBER) in situ hybridization.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed de novo DLBCL, according to the World Health Organization (WHO) classification:\n\n * registered in Samsung Medical Center (SMC) Lymphoma Cohort Study I/II (ClinicalTrials.gov Identifier: NCT00822731, NCT01877109) or identified from Asan Medical Center (AMC) medical database:\n * adequate amount and quality of paraffin-embedded biopsy specimen or unstained slides for EBV-encoded RNA (EBER) in situ hybridization.\n\nExclusion Criteria:\n\n* Patients with unknown EBV status, primary central nervous system (CNS) lymphoma, post-transplant lymphoproliferative disorders (PTLDs), and HIV-positive DLBCL were excluded in the study.'}, 'identificationModule': {'nctId': 'NCT02060435', 'briefTitle': 'Epstein-Barr Virus Status in Diffuse Large B Cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'The Impact of the Epstein-Barr Virus Status on Clinical Outcome in Diffuse Large B Cell Lymphoma', 'orgStudyIdInfo': {'id': '2013-07-101-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EBER+ AMC', 'description': 'EBV+DLBCL patients in Asan Medical Center', 'interventionNames': ['Other: EBER']}, {'label': 'EBER+ SMC', 'description': 'EBV+DLBCL patients in Samsung Medical Center', 'interventionNames': ['Other: EBER']}, {'label': 'EBER- SMC', 'description': 'EBV-DLBCL patients in Samsung Medical Center'}], 'interventions': [{'name': 'EBER', 'type': 'OTHER', 'description': 'EBV RNA was detected by an in situ hybridization (ISH) technique using the EBV ISH kit (Leica Microsystems, Bannockburn, IL, USA).', 'armGroupLabels': ['EBER+ AMC', 'EBER+ SMC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Won Seog Kim, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Won Seog Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}