Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT03491605
Status:
RECRUITING
Last Update Posted:
2021-02-10
First Post:
2018-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surveillance and Tracking the Outcomes of Chronic Latent EBV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D051359', 'term': 'Lymphohistiocytosis, Hemophagocytic'}], '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': 'D015616', 'term': 'Histiocytosis, Non-Langerhans-Cell'}, {'id': 'D015614', 'term': 'Histiocytosis'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '1. perepheral blood sample of the subjects who have high load peripheral EBV-DNA\n2. tumor tissues of the subjests who progress to hematological malignancies during the follow-up process'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-09', 'studyFirstSubmitDate': '2018-04-02', 'studyFirstSubmitQcDate': '2018-04-02', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hematological malignancies', 'timeFrame': 'Five years or more if necessary', 'description': 'including Burkitt lymphoma, EBV+ B-cell lymphoproliferative diseases, extranodal NK/T-cell lymphoma of nasal type (ENKL), aggressive NK-cell leukemia (ANKL), classic Hodgkin lymphoma, and Chronic active Epstein-Barr virus infection (CAEBV).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic EBV infection, hemophagocytic lymphohistiocytosis'], 'conditions': ['EBV Infection']}, 'descriptionModule': {'briefSummary': 'Immunocompetent subjects with high load of Epstein-Barr virus DNA (EBV-DNA) in peripheral blood will be enrolled and prospectively followed up to track the natural histories of the chronic high load of EBV virus. The primary goal of this study is to explore the association of peripheral high load of EBV with the hematological malignancies, and second goal is to investigate the genetic mechanisms of immune escape and tumorigenesis of chronic EBV infection.', 'detailedDescription': 'Epstein-Barr virus (EBV) is an oncogenic virus implicated in the pathogenesis of a variety of human hematological malignancies such as lymphomas, hemophagocytic lymphohistiocytosis and chronic active EBV disease. While chronic latent EBV infection（especially carriers with persistent high load of EBV-DNA copy number）is the gray zone between the primary infection and the hematological malignancies, which is rarely concerned. Previous work has prompted the heterogeneities of EBV infection, such as racial heterogeneity, viral load heterogeneity and heterogeneity of infected target cells. It is of great significance to prospectively track the transforming process and elucidate the association of chronic EBV infection and hemophagocytic lymphohistiocytosis. Healthy subjects who was found to have high EBV-DNA load （\\>1×103 copies/ml）in peripheral blood during the physical examination were enrolled and followed up by telephone or face-to-face interview periodically. The primary outcome is hematological malignancies including Burkitt lymphoma, EBV+ B-cell lymphoproliferative diseases, extranodal NK/T-cell lymphoma of nasal type (ENKL), aggressive NK-cell leukemia (ANKL), classic Hodgkin lymphoma,EBV-associated hemophagocytic lymphohistiocytosis and Chronic active Epstein-Barr virus infection (CAEBV). The Exploratory purpose of this study is to investigate of genetic mechanisms of immune escape and tumorigenesis of EBV infection. Subgroup analysis will performed in subjects with mild high load (\\>1×103 copies/ml and \\<1×104 copies/ml) and severe high load (\\>1×104 copies/ml) of EBV-DNA copies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A cohort of immunocompetent subjects with high load (\\>1×103 copies/ml) of Epstein-Barr virus DNA (EBV-DNA) in peripheral blood will be enrolled and prospectively followed up to track the natural histories of the chronic latent EBV infection.The subjects were enrolled from healthy examers in Tongji Hospitoal attached to Huazhong University of Science and Techonology. There is no limitation regarding to age and sex.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. immunocompetent subjects who was found to have high EBV-DNA load （\\>1×103 copies/ml）in peripheral blood during the physical examination\n2. Willing to be followed up by telephone or face-to-face interview\n\nExclusion Criteria:\n\n1. Subjects with defined immunodeficiency\n2. Subjects who have taken or are going to take immunosuppressive drugs.\n3. Subjects Diagnosed a validated hematopathy\n4. Subjects diagnosis as precancerous lesion or malignant tumor and the life expectancy is less than 1 year.\n5. psychological illness which does not allow subjects to understand the study and participate following his own free will\n6. Pregnant woman\n7. no written informed consent'}, 'identificationModule': {'nctId': 'NCT03491605', 'briefTitle': 'Surveillance and Tracking the Outcomes of Chronic Latent EBV Infection', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'Study to Surveil and Track the Outcomes of Chronic Latent EBV Infection Based on Healthy Volunteers Undergoing Routine Inspection', 'orgStudyIdInfo': {'id': 'TJH0002017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'peripheral EBV-DNA load', 'description': 'subjects with high load (\\>1×103 copies/ml）of EBV-DNA copies in peripheral blood.', 'interventionNames': ['Other: peripheral EBV-DNA load']}], 'interventions': [{'name': 'peripheral EBV-DNA load', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['peripheral EBV-DNA load']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jin Huang, PHD', 'role': 'CONTACT', 'email': 'hj20130318@163.com', 'phone': '86-15926444318'}], 'facility': 'Tongji hospital, Tongji medical collage of HUST', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Jin Huang, PhD.and MD.', 'role': 'CONTACT', 'email': 'hj20130318@163.com', 'phone': '86-15926444318', 'phoneExt': '86-83663609'}, {'name': 'Jianfeng Zhou, PhD.and MD.', 'role': 'CONTACT', 'email': 'jfzhou@tjh.tjmu.edu.cn', 'phone': '86-13627284963'}], 'overallOfficials': [{'name': 'Jianfeng Zhou, PhD.and MD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Director of Department of Hematology in Tongji Hospital，HUST'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It is not yet known if there will be a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Hematology,Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology', 'investigatorFullName': 'Jianfeng Zhou', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}