Clinical trial NCT03491605: Surveillance and Tracking the Outcomes of Chronic Latent EBV Infection
Official title: Study to Surveil and Track the Outcomes of Chronic Latent EBV Infection Based on Healthy Volunteers Undergoing Routine Inspection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: EBV Infection
Keywords: chronic EBV infection, hemophagocytic lymphohistiocytosis
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: hematological malignancies
timeFrame: Five years or more if necessary
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji hospital, Tongji medical collage of HUST
state: Hubei
Study officials:
affiliation: Director of Department of Hematology in Tongji Hospital，HUST
name: Jianfeng Zhou, PhD.and MD.
role: STUDY_CHAIR
References: