Early Detection of Epstein-Barr Virus Related Disease.
- Conditions
- MononucleosisEpstein-Barr Virus InfectionsEpstein-Barr ViraemiaEpstein-Barr Virus-Related Hodgkin LymphomaEpstein-Barr Virus-Related Non-Hodgkin LymphomaPost-transplant Lymphoproliferative DisorderHemophagocytic LymphohistiocytosesHemophagocytosisEpstein-Barr Virus Related Malignancy
- Registration Number
- NCT03546101
- Lead Sponsor
- University of Aarhus
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1527
- Patients suspected for having EBV disease.
- If the patients has any contraindications for blood sampling.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of proven EBV disease 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 From time of blood sampling up to 24 months. Symptoms compatible with EBV disease combined with a positive EBV-PCR
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Aarhus University Hospital
🇩🇰Aarhus, Central Region Of Denmark, Denmark