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Surveillance and Tracking the Outcomes of Chronic Latent EBV Infection

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ClinicalTrials.gov Identifier: NCT03491605
Recruitment Status : Not yet recruiting
First Posted : April 9, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Jianfeng Zhou, Huazhong University of Science and Technology

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.

Condition or disease Intervention/treatment
EBV Infection Other: peripheral EBV-DNA load

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
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study to Surveil and Track the Outcomes of Chronic Latent EBV Infection Based on Healthy Volunteers Undergoing Routine Inspection
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2028

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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).


Biospecimen Retention:   Samples With DNA
  1. perepheral blood sample of the subjects who have high load peripheral EBV-DNA
  2. tumor tissues of the subjests who progress to hematological malignancies during the follow-up process


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491605


Contacts
Contact: Jin Huang, PhD.and MD. 86-15926444318 ext 86-83663609 hj20130318@163.com
Contact: Jianfeng Zhou, PhD.and MD. 86-13627284963 jfzhou@tjh.tjmu.edu.cn

Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
Study Chair: Jianfeng Zhou, PhD.and MD. Director of Department of Hematology in Tongji Hospital,HUST and Director of Immunotherapy Reseach Center for Hematologic Disease of Hubei Province

Responsible Party: Jianfeng Zhou, Director of Hematology,Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03491605     History of Changes
Other Study ID Numbers: TJH0002017
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make IPD available.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jianfeng Zhou, Huazhong University of Science and Technology:
chronic EBV infection, hemophagocytic lymphohistiocytosis

Additional relevant MeSH terms:
Infection
Communicable Diseases
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections