EBV InfectionNCT03491605
Surveillance and Tracking the Outcomes of Chronic Latent EBV Infection
An observational study of EBV Infection, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- EBV Infection
- What is being tested?
- peripheral EBV-DNA load
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 31 Dec 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji hospital, Tongji medical collage of HUST
Wuhan, Hubei, 430000
Jin Huang, PHD, 86-15926444318, hj20130318@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- EBV Infection
- Being tested
- peripheral EBV-DNA load
- Keywords
- chronic EBV infection, hemophagocytic lymphohistiocytosis
- Medical subject headings
- Epstein-Barr Virus Infections, Lymphohistiocytosis, Hemophagocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral EBV-DNA loadOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| peripheral EBV-DNA load | subjects with high load (>1×103 copies/ml）of EBV-DNA copies in peripheral blood. Receives: Other: peripheral EBV-DNA load |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Five years or more if necessary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start1 Jul 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EBV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Zhou, Huazhong University of Science and Technology
- Investigators
- Jianfeng Zhou, PhD.and MD., Study chair, Director of Department of Hematology in Tongji Hospital，HUST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491605
- Sponsor's protocol ID
- TJH0002017
- Status last verified
- Feb 2021
- First submitted
- 2 Apr 2018
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.