Surveillance and Tracking the Outcomes of Chronic Latent EBV Infection

NCT03491605 | Recruiting DMC

• 1 other identifier: TJH0002017
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

EBV Infection

Keywords

chronic EBV infection, hemophagocytic lymphohistiocytosis

Outcome Measures

Primary Outcomes (1)

• 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, and Chronic active Epstein-Barr virus infection (CAEBV).

  Five years or more if necessary

Study Arms (1)

peripheral EBV-DNA load

subjects with high load (\>1×103 copies/ml）of EBV-DNA copies in peripheral blood.

Other: peripheral EBV-DNA load

Interventions

peripheral EBV-DNA load OTHER

No intervention

peripheral EBV-DNA load

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji hospital, Tongji medical collage of HUST

Wuhan, Hubei, 430000, China

RECRUITING

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

MeSH Terms

Conditions

Epstein-Barr Virus Infections; Lymphohistiocytosis, Hemophagocytic

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jianfeng Zhou, PhD.and MD.

  Director of Department of Hematology in Tongji Hospital，HUST

  STUDY CHAIR

Central Study Contacts

Jin Huang, PhD.and MD.

CONTACT

86-15926444318; hj20130318@163.com

Jianfeng Zhou, PhD.and MD.

CONTACT

86-13627284963; jfzhou@tjh.tjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hematology,Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 9, 2018
• Study Start: July 1, 2019
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

CN (1)