Clinical trial NCT03546101: Early Detection of Epstein-Barr Virus Related Disease.
Official title: Early Detection of Epstein-Barr Virus Related Disease. Improving Quantification of EBV in Blood Samples Using Polymerase Chain Reaction.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-transplant Lymphoproliferative Disorder
Mononucleosis
Epstein-Barr Virus Infections
Epstein-Barr Virus Related Malignancy
Epstein-Barr Viraemia
Epstein-Barr Virus-Related Hodgkin Lymphoma
Epstein-Barr Virus-Related Non-Hodgkin Lymphoma
Hemophagocytic Lymphohistiocytoses
Hemophagocytosis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2018-06-06
Enrollment: 1527
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Transplant recipients undergoing monitoring for EBV and patients suspected or diagnosed with PTLD.

Patients undergoing hematopoietic stem cell transplantation and patients with hemophagocytosis.

Children undergoing transplantation. Children diagnosed with hemophagocytic lymphohistiocytosis.

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.

Eligibility criteria: Inclusion Criteria:

* Patients suspected for having EBV disease.

Exclusion Criteria:

* If the patients has any contraindications for blood sampling.

Primary outcomes:
measure: Incidence of proven EBV disease
timeFrame: From time of blood sampling up to 24 months.
measure: Incidence of probable EBV disease
timeFrame: From time of blood sampling up to 24 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Central Region Of Denmark
Study officials:
affiliation: University of Aarhus
name: Lene Ugilt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Clin Virol. 2023 Oct;167:105579. doi: 10.1016/j.jcv.2023.105579. Epub 2023 Aug 30.