Surveillance and Tracking the Outcomes of Chronic Latent EBV Infection

February 9, 2021 updated by: Jianfeng Zhou, Huazhong University of Science and Technology

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jin Huang, PhD.and MD.
  • Phone Number: 86-83663609 86-15926444318
  • Email: hj20130318@163.com

Study Contact Backup

Study Locations

    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Tongji hospital, Tongji medical collage of HUST
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
peripheral EBV-DNA load
subjects with high load (>1×103 copies/ml)of EBV-DNA copies in peripheral blood.
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hematological malignancies
Time Frame: 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).
Five years or more if necessary

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Jianfeng Zhou, PhD.and MD., Director of Department of Hematology in Tongji Hospital,HUST

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2029

Study Registration Dates

First Submitted

April 2, 2018

First Submitted That Met QC Criteria

April 2, 2018

First Posted (Actual)

April 9, 2018

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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