ClinicalTrials.gg
RecruitingNCT03491605Updated Feb 10, 2021

Surveillance and Tracking the Outcomes of Chronic Latent EBV Infection

An observational study in EBV Infection, sponsored by Huazhong University of Science and Technology. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2021-02-10.

Sponsored by Huazhong University of Science and Technology · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Jul 2019; still recruiting 7 years 4 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 36 studies in Epstein-Barr Virus Infections with a site in China — 17 open to participants now, 18 under way, 2 of them phase 3. Epstein-Barr Virus Infections · China.

Planned enrollment
2nd of 14
10,000 · median 306
Started
2019
with 2 others
Observational
14 of 36
8 open now
Primary completion
2024-12
later than 0 of 17 live
Registered
8th of 36
by date

Among the 36 studies in Epstein-Barr Virus Infections with a site in China, this one is the 2nd largest by planned enrollment of the 14 observational ones that give a count, is one of 3 that started in 2019, is one of 14 observational ones, reaches primary completion later than 0 of the 17 other live ones, and was the 8th registered.

Epstein-Barr Virus Infections

175 studies on the registry are indexed under Epstein-Barr Virus Infections; 60 are open to participants now.

Browse Epstein-Barr Virus Infections studies →

Open to participants now

17 of the 36 studies in Epstein-Barr Virus Infections with a site in China are open now. Recruiting first, the newest first:

11 more — sign in →

All 17 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 43 Epstein-Barr Virus Infections studies recruiting now, 23 (53%) set no upper age limit and 16 (37%) stop at 75 or younger; 23 take children under 18; 6 take healthy volunteers.

This study: all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 36 studies in Epstein-Barr Virus Infections with a site in China, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • EBV Infection

Keywords

  • chronic EBV infection, hemophagocytic lymphohistiocytosis
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Subjects with defined immunodeficiency
  2. Subjects who have taken or are going to take drugs.
  3. Subjects Diagnosed a validated hematopathy
  4. Subjects diagnosis as precancerous lesion or malignant tumor and the 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Otherperipheral EBV-DNA load

    No intervention

06

What researchers measure

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).

    Time frame: Five years or more if necessary

07

Study locations

1 of 1 sites recruiting
  • Tongji hospital, Tongji medical collage of HUST
    Wuhan, Hubei 430000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — It is not yet known if there will be a plan to make IPD available.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2019 (actual). Primary completion is estimated for Dec 2024, 65 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2018
First posted
Apr 9, 2018
StartActual
Jul 1, 2019
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2029
Last update
Feb 10, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03491605
Responsible party
Jianfeng Zhou (Director of Hematology,Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology, Huazhong University of Science and Technology) — Principal investigator
First posted
Apr 9, 2018
Start date
Jul 1, 2019
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Feb 10, 2021

Study contacts

Jin Huang, PhD.and MD.
Contact
hj20130318@163.com
86-15926444318 ext. 86-83663609
Jianfeng Zhou, PhD.and MD.
Contact
jfzhou@tjh.tjmu.edu.cn
86-13627284963
Jianfeng Zhou, PhD.and MD.
study chair · Director of Department of Hematology in Tongji Hospital,HUST

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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