Early Detection of Epstein-Barr Virus Related Disease.

University of Aarhus

Status: Completed

Conditions: Mononucleosis; Hemophagocytosis; Epstein-Barr Virus Related Malignancy; Epstein-Barr Virus-Related Hodgkin Lymphoma; Hemophagocytic Lymphohistiocytoses; Epstein-Barr Virus Infections; Epstein-Barr Viraemia; Epstein-Barr Virus-Related Non-Hodgkin Lymphoma; Post-transplant Lymphoproliferative Disorder

Study type: Observational

Funder types: Other

Identifiers

NCT03546101

1-16-02-685-16 (Other Identifier)

EBV-KMA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,527 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients suspected for having EBV disease.

Exclusion criteria

• If the patients has any contraindications for blood sampling.

Trial design

1,527 participants in 3 patient groups

Department of Kidney Medicine

Description:

Primarily transplant recipients undergoing monitoring for EBV and patients suspected for having PTLD.

Department of Hematology

Description:

Patients diagnosed with PTLD and other kinds of lymphoma. Patients undergoing hematopoietic stem cell transplantation and patients with hemophagocytosis.

Department of pediatrics

Description:

Children undergoing transplantation. Children diagnosed with hemophagocytic lymphohistiocytosis.