NCT03374566

Brief Summary

The purpose of this study is to investigate the immune responses associated with Epstein-Barr virus infections, and to find out the possible immunodeficiency that may be linked to severe Epstein-Barr virus infections.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2017

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

4.9 years

First QC Date

December 12, 2017

Last Update Submit

February 8, 2023

Conditions

Keywords

Epstein-Barr Virus InfectionsImmunodeficiencyScreeningImmunologic Function

Outcome Measures

Primary Outcomes (1)

  • Immunodeficiency incidence in patients with severe EBV infection

    We will investigate immunodeficiency incidence in patients with severe EBV infection.

    5 years

Study Arms (1)

Screened patients

Immunodeficiency screening: Heparinized peripheral blood is obtained from patients with severe EBV infections for immunological function assays and genetic analysis, when current screening is performed after parents' information and consent.

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

We will evaluate immunodeficiency incidence in patients with severe EBV infection

You may qualify if:

  • \. Age:birth to 18 years 2. Severe Epstein-Barr Virus infection

You may not qualify if:

  • \. Lack of parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Location

Related Publications (6)

  • Worth AJ, Houldcroft CJ, Booth C. Severe Epstein-Barr virus infection in primary immunodeficiency and the normal host. Br J Haematol. 2016 Nov;175(4):559-576. doi: 10.1111/bjh.14339. Epub 2016 Oct 17.

    PMID: 27748521BACKGROUND
  • Shabani M, Nichols KE, Rezaei N. Primary immunodeficiencies associated with EBV-Induced lymphoproliferative disorders. Crit Rev Oncol Hematol. 2016 Dec;108:109-127. doi: 10.1016/j.critrevonc.2016.10.014. Epub 2016 Nov 2.

    PMID: 27931829BACKGROUND
  • Palendira U, Rickinson AB. Primary immunodeficiencies and the control of Epstein-Barr virus infection. Ann N Y Acad Sci. 2015 Nov;1356:22-44. doi: 10.1111/nyas.12937. Epub 2015 Sep 28.

    PMID: 26415106BACKGROUND
  • Taylor GS, Long HM, Brooks JM, Rickinson AB, Hislop AD. The immunology of Epstein-Barr virus-induced disease. Annu Rev Immunol. 2015;33:787-821. doi: 10.1146/annurev-immunol-032414-112326. Epub 2015 Feb 11.

    PMID: 25706097BACKGROUND
  • Fujiwara S, Kimura H, Imadome K, Arai A, Kodama E, Morio T, Shimizu N, Wakiguchi H. Current research on chronic active Epstein-Barr virus infection in Japan. Pediatr Int. 2014 Apr;56(2):159-66. doi: 10.1111/ped.12314.

    PMID: 24528553BACKGROUND
  • Eligio P, Delia R, Valeria G. EBV Chronic Infections. Mediterr J Hematol Infect Dis. 2010 Aug 10;2(1):e2010022. doi: 10.4084/MJHID.2010.022.

    PMID: 21415952BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Heparinized peripheral blood is obtained from patients with severe EBV infections. Samples is performed after parents' information and consent.

MeSH Terms

Conditions

Epstein-Barr Virus InfectionsImmunologic Deficiency Syndromes

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsImmune System Diseases

Study Officials

  • Jinqiao Sun, Ph.D.,M.D

    Children's Hospital of Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 12, 2017

First Posted

December 15, 2017

Study Start

December 1, 2017

Primary Completion

October 30, 2022

Study Completion

February 1, 2023

Last Updated

February 9, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations