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临床试验/NCT03491605
NCT03491605招募中不适用

Study to Surveil and Track the Outcomes of Chronic Latent EBV Infection Based on Healthy Volunteers Undergoing Routine Inspection

Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
1
主要终点
hematological malignancies

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • immunocompetent subjects who was found to have high EBV-DNA load (>1×103 copies/ml)in peripheral blood during the physical examination
  • Willing to be followed up by telephone or face-to-face interview

排除标准

  • Subjects with defined immunodeficiency
  • Subjects who have taken or are going to take immunosuppressive drugs.
  • Subjects Diagnosed a validated hematopathy
  • Subjects diagnosis as precancerous lesion or malignant tumor and the life expectancy is less than 1 year.
  • psychological illness which does not allow subjects to understand the study and participate following his own free will
  • Pregnant woman
  • no written informed consent

结局指标

主要结局

hematological malignancies

时间窗: Five years or more if necessary

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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jianfeng Zhou

Director of Hematology,Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology

Huazhong University of Science and Technology

研究点 (1)

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