Early Detection of Epstein-Barr Virus Related Disease.

Post-transplant Lymphoproliferative Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03546101
• Other study ID #: EBV-KMA
• Secondary ID: 1-16-02-685-16
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: May 1, 2023

Study information

• Verified date: December 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1527
• Est. completion date: May 1, 2023
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients suspected for having EBV disease.

Exclusion Criteria:

• If the patients has any contraindications for blood sampling.

Related Conditions & MeSH terms

• Epstein-Barr Viraemia
• Epstein-Barr Virus Infections
• Epstein-Barr Virus Related Malignancy
• Epstein-Barr Virus-Related Hodgkin Lymphoma
• Epstein-Barr Virus-Related Non-Hodgkin Lymphoma
• Hemophagocytic Lymphohistiocytoses
• Hemophagocytosis
• Lymphohistiocytosis, Hemophagocytic
• Lymphoma
• Lymphoproliferative Disorders
• Mononucleosis
• Post-transplant Lymphoproliferative Disorder
• Viremia
• Virus Diseases

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Central Region Of Denmark

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Ludvigsen LUP, Andersen AS, Hamilton-Dutoit S, Jensen-Fangel S, Bottger P, Handberg KJ, Ivarsen P, d'Amore F, Bibby BM, Albertsen BK, Jespersen B, Thomsen MK. A prospective evaluation of the diagnostic potential of EBV-DNA in plasma and whole blood. J Cli — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of proven EBV disease	Symptoms compatible with EBV disease combined with a tissue biopsy positive for EBV	From time of blood sampling up to 24 months.
Primary	Incidence of probable EBV disease	Symptoms compatible with EBV disease combined with a positive EBV-PCR	From time of blood sampling up to 24 months.