ClinicalTrials.gov record NCT03491605

Surveillance and Tracking the Outcomes of Chronic Latent EBV Infection

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.The registry record was last updated on Feb 10, 2021, about 5 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a prospective observational study of immunocompetent people found to have a high EBV-DNA load (>1×10^3 copies/ml) in blood during routine health exams. Enrolled participants are followed by telephone or face-to-face visits to track whether they develop hematological malignancies over time. The study also collects material to explore genetic mechanisms related to immune escape and tumor development.

What it is studying. The study aims to see if a persistently high level of EBV-DNA in peripheral blood is associated with later hematological cancers and related disorders, and to investigate genetic changes that might explain immune escape and tumorigenesis. Subgroup analyses separate mild high load (>1×10^3 and <1×10^4 copies/ml) from severe high load (>1×10^4 copies/ml).

What the researchers hope to learn. To determine whether persistent high EBV-DNA in blood is linked to future hematological malignancies and to identify genetic mechanisms of immune escape and tumor development in chronic EBV infection.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • peripheral EBV-DNA load

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants give written consent and are followed prospectively with periodic telephone or face-to-face interviews and monitoring of their health. Researchers will record whether hematological malignancies develop; follow-up may continue five years or longer if needed. The registry states an exploratory aim to investigate genetic mechanisms but does not detail what additional samples or tests participants will undergo; the study lists no interventional procedures.

How the study is structured. A prospective observational cohort: people with high EBV-DNA found during routine exams are enrolled and followed over time. There is no treatment assigned. Follow-up is by periodic telephone or face-to-face contact, with outcome tracking for hematological malignancies for five years or longer if needed.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under EBV Infection. Does it apply to my diagnosis?
  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on hemophagocytic lymphohistiocytosis

Clinical trials34 trials listed for hemophagocytic lymphohistiocytosisEvery trial the registry lists for hemophagocytic lymphohistiocytosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in hemophagocytic lymphohistiocytosis researchLatest monthly update: September 2026. Includes: Multiple test results. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jul 1, 2019
Primary completion
Dec 31, 2024 (estimated)
Study completion
Dec 31, 2029 (estimated)
Target enrollment
10000 participants (estimated)
Last updated on registry
Feb 10, 2021
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Huazhong University of Science and Technology
Principal investigator
Jianfeng Zhou, Director of Hematology,Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology
Huazhong University of Science and Technology

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

immunosuppressive
A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
life expectancy
Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
Healthy subjects
People who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
primary outcome
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials