Tracking outcomes of chronic EBV infection
Study to Surveil and Track the Outcomes of Chronic Latent EBV Infection Based on Healthy Volunteers Undergoing Routine Inspection
This study is tracking people with high levels of Epstein-Barr virus in their blood to see if it leads to blood cancers and to understand how the virus might affect the immune system.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Sex | All |
| Sponsor | Huazhong University of Science and Technology Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT03491605 on ClinicalTrials.gov |
What this trial studies
This observational study enrolls immunocompetent individuals with a high load of Epstein-Barr virus (EBV) DNA in their blood to monitor the natural history of chronic EBV infection. Participants will be followed up through interviews to assess the association between high EBV load and the development of hematological malignancies. The study also aims to investigate the genetic mechanisms behind immune escape and tumorigenesis related to chronic EBV infection. The primary outcomes include various types of hematological malignancies and chronic active EBV disease.
Who should consider this trial
Good fit: Ideal candidates are immunocompetent individuals with a high EBV-DNA load greater than 1×10^3 copies/ml found during physical examinations.
Not a fit: Patients with defined immunodeficiency, those on immunosuppressive drugs, or those diagnosed with hematological malignancies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of chronic EBV infection and its link to serious blood cancers, potentially leading to better prevention and treatment strategies.
How similar studies have performed: While there is ongoing research into EBV and its associations with malignancies, this specific observational approach focusing on chronic latent EBV infection is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Wuhan, Hubei
- Tongji hospital, Tongji medical collage of HUST — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Jin Huang, PhD.and MD.
- Email: hj20130318@163.com
- Phone: 86-15926444318
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.