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Immunodeficiency for Severe Epstein-Barr Virus Infection

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ClinicalTrials.gov Identifier: NCT03374566
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Jinqiao Sun, Children's Hospital of Fudan University

Tracking Information
First Submitted Date December 12, 2017
First Posted Date December 15, 2017
Last Update Posted Date December 24, 2018
Actual Study Start Date December 1, 2017
Estimated Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 12, 2017)
Immunodeficiency incidence in patients with severe EBV infection [ Time Frame: 5 years ]
We will investigate immunodeficiency incidence in patients with severe EBV infection.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03374566 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Immunodeficiency for Severe Epstein-Barr Virus Infection
Official Title Screening for Immunodeficiency Diseases in Patients With Severe Epstein-Barr Virus Infection
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.
Detailed Description

Epstein-Barr virus (EBV) belongs to herpesviridae family, which infects more than 90% of the population. EBV infection is usually asymptomatic and establishes lifelong persistence in the host, although primary infection later than adolescence frequently results in infectious mononucleosis (IM). Rarely, individuals may develop a subgroup of EBV-associated life threatening complications (including liver dysfunction, haemophagocytosis and malignancy).

Although EBV-infected B cells have the potential for proliferation, they are effectively removed by the EBV-specific cytotoxic T cells (CTL). In the immunocompetent hosts, natural killer (NK) cells and antigen-specific cluster designation 8 (CD8+) T-cells play an important role in inhibiting progression of primary EBV infection by granule-mediated cytotoxicity. The immune system is necessary to control the virus-induced transformation and the B-cell unlimited proliferation.

Primary immunodeficiency are a heterogeneous group of hereditary diseases that are associated with compromised immune responses. There are a number of immunodeficiency resulting in inability of immune system to control EBV infection, for example X-linked Lymphoproliferative disease (XLP)/signaling lymphocyte activation molecule (SLAM)-associated protein (SAP) deficiency, X-linked inhibitor of apoptosis (XIAP) deficiency, cluster of differentiation antigen 27 (CD27) deficiency, interleukin-2-inducible T-cell kinase (ITK) deficiency, and so on. Whereas, some other clinical states associated with EBV-susceptibility remain largely unknown. Rare EBV-infected individuals without apparent immunodeficiency also present with persistent IM-like symptoms, hepatosplenomegaly, liver dysfunction, lymphadenopathy and haemophagocytic lymphohistiocytosis.

Patients presenting with severe EBV infections should be focused on early identification of a possible primary immunodeficiency or a chronic active EBV infection clinical condition (CAEBV) and haemophagocytic lymphohistiocytosis(HLH). Immunological phenotyping of NK-, T- and B-cell differentiation, and functional assays including cytotoxic cell killing function and cytotoxic granule release, provide a useful identification for clinical conditions inability to control EBV infections. Genomic DNA is isolated from peripheral blood mononuclear cells and will be amplified to screen for possible immunodeficiency.

The reasons for those patients inability to control the EBV infection are still unknown. However no effective treatment is currently available, those patients might benefit from early hematopoietic stem cell transplantation (HSCT). Through this study, we hope to identify the unknown immune immunodeficiency and pathophysiology of those EBV-associated conditions. The investigators propose to help make early diagnosis and develop effective therapies.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Heparinized peripheral blood is obtained from patients with severe EBV infections. Samples is performed after parents' information and consent.
Sampling Method Non-Probability Sample
Study Population We will evaluate immunodeficiency incidence in patients with severe EBV infection
Condition
  • Epstein-Barr Virus Infections
  • Immunodeficiency
Intervention Not Provided
Study Groups/Cohorts 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 12, 2017)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 30, 2022
Estimated Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 1. Lack of parental consent
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jinqiao Sun, Ph.D.,M.D 86-21-64932909 jinqiaosun@sina.com
Contact: Weili Yan, Ph.D. 86-21-64931913 yanwl@fudan.edu.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03374566
Other Study ID Numbers EBV
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Jinqiao Sun, Children's Hospital of Fudan University
Study Sponsor Children's Hospital of Fudan University
Collaborators Not Provided
Investigators
Principal Investigator: Jinqiao Sun, Ph.D.,M.D Children's Hospital of Fudan University
PRS Account Children's Hospital of Fudan University
Verification Date December 2018