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Clinical Trials/NCT03546101
NCT03546101
Completed
Not Applicable

Early Detection of Epstein-Barr Virus Related Disease. Improving Quantification of EBV in Blood Samples Using Polymerase Chain Reaction.

University of Aarhus1 site in 1 country1,527 target enrollmentStarted: November 1, 2017Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
1,527
Locations
1
Primary Endpoint
Incidence of proven EBV disease

Overview

Brief Summary

Epstein-Barr virus (EBV) is one of several herpesviruses that cause disease in humans. EBV virus has an oncogenic potential, and it has been associated with the development of a wide range of cancers. Previous studies have shown a close association between EBV and Post-Transplant Lymphoproliferative disorder (PTLD) in transplant recipients. As part of a preventive approach against PTLD, several transplantation units now monitor the occurrence of EBV-DNAemia after transplantation. However, there is little evidence to guide this strategy; nor is there consensus concerning either the best specimen to use for EBV analysis (whole blood or plasma).

In this study investigators aim to optimise and validate a polymerase chain reaction (PCR)-test for EBV-DNA on, respectively, whole blood, plasma and a combination of plasma and lymphocytes.

The investigators wish to determine which of the three tests best predicts current and future risk of development of EBV-related diseases such as mononucleosis and PTLD.

Detailed Description

EBV is one of several herpesviruses that cause disease in humans. Primary EBV infection usually occurs in early childhood and is generally asymptomatic, while later infection may cause mononucleosis. As with other herpesviruses, primary infection is followed by persistent (lifelong) infection. EBV virus has an oncogenic potential, and it has been associated with the development of a wide range of cancers. Previous studies have shown a close association between EBV and PTLD in transplant recipients. As part of a preventive approach against PTLD, several transplantation units now monitor the occurrence of EBV-DNAemia after transplantation. However, there is little evidence to guide this strategy; nor is there consensus concerning either the best specimen to use for EBV analysis (whole blood or plasma) or the appropriate clinical action to take if EBV-DNAemia is detected.

In this study investigators aim to optimise and validate a polymerase chain reaction (PCR)-test for EBV-DNA on, respectively, whole blood and a combination of plasma and lymphocytes.

Results obtained with the two new methods will be compared with those from the already established World Health Organization (WHO) standardised EBV-PCR test on ethylenediaminetetraacetic acid (EDTA)-plasma. The result of all three tests will be evaluated relative to EBV-related symptoms and other diseases.

The investigators wish to determine which of the three tests best predicts current and future risk of development of EBV-related diseases such as mononucleosis and PTLD.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients suspected for having EBV disease.

Exclusion Criteria

  • If the patients has any contraindications for blood sampling.

Outcomes

Primary Outcomes

Incidence of proven EBV disease

Time Frame: From time of blood sampling up to 24 months.

Symptoms compatible with EBV disease combined with a tissue biopsy positive for EBV

Incidence of probable EBV disease

Time Frame: From time of blood sampling up to 24 months.

Symptoms compatible with EBV disease combined with a positive EBV-PCR

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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