- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03491605
Surveillance and Tracking the Outcomes of Chronic Latent EBV Infection
February 9, 2021 updated by: Jianfeng Zhou, Huazhong University of Science and Technology
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.
Study Overview
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.
Study Type
Observational
Enrollment (Anticipated)
10000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jin Huang, PhD.and MD.
- Phone Number: 86-83663609 86-15926444318
- Email: hj20130318@163.com
Study Contact Backup
- Name: Jianfeng Zhou, PhD.and MD.
- Phone Number: 86-13627284963
- Email: jfzhou@tjh.tjmu.edu.cn
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430000
- Recruiting
- Tongji hospital, Tongji medical collage of HUST
-
Contact:
- Jin Huang, PHD
- Phone Number: 86-15926444318
- Email: hj20130318@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
peripheral EBV-DNA load
subjects with high load (>1×103 copies/ml)of EBV-DNA copies in peripheral blood.
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hematological malignancies
Time Frame: Five years or more if necessary
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Jianfeng Zhou, PhD.and MD., Director of Department of Hematology in Tongji Hospital,HUST
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2019
Primary Completion (Anticipated)
December 31, 2024
Study Completion (Anticipated)
December 31, 2029
Study Registration Dates
First Submitted
April 2, 2018
First Submitted That Met QC Criteria
April 2, 2018
First Posted (Actual)
April 9, 2018
Study Record Updates
Last Update Posted (Actual)
February 10, 2021
Last Update Submitted That Met QC Criteria
February 9, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJH0002017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
It is not yet known if there will be a plan to make IPD available.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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