Early Detection of Epstein-Barr Virus Related Disease.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Department of Kidney Medicine Primarily transplant recipients undergoing monitoring for EBV and patients suspected for having PTLD. |
|
| Department of Hematology Patients diagnosed with PTLD and other kinds of lymphoma. Patients undergoing hematopoietic stem cell transplantation and patients with hemophagocytosis. |
|
| Department of pediatrics Children undergoing transplantation. Children diagnosed with hemophagocytic lymphohistiocytosis. |
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients suspected for having EBV disease.
Exclusion Criteria:
- If the patients has any contraindications for blood sampling.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aarhus University Hospital | Aarhus | Central Region Of Denmark | Denmark | 8200 |
Sponsors and Collaborators
- University of Aarhus
- Aarhus University Hospital
Investigators
- Principal Investigator: Lene Ugilt, MD, University of Aarhus
Study Documents (Full-Text)
None provided.More Information
Publications
- Fryer JF, Heath A, Wilkinson DE, Minor, Phillip D World Health Organization. Biologicals Unit WHO Expert Committee on Biological Standardization (2011 : Geneva, Switzerland). Collaborative Study to Evaluate the Proposed 1st WHO International Standards for Epstein-Barr Virus (EBV) for Nucleic Acid Amplification Technology (NAT)-Based Assays . 2011; WHO/BS/2011.2172
- Knight JS, Tsodikov A, Cibrik DM, Ross CW, Kaminski MS, Blayney DW. Lymphoma after solid organ transplantation: risk, response to therapy, and survival at a transplantation center. J Clin Oncol. 2009 Jul 10;27(20):3354-62. doi: 10.1200/JCO.2008.20.0857. Epub 2009 May 18.
- Maksten EF, Vase MØ, Kampmann J, d'Amore F, Møller MB, Strandhave C, Bendix K, Bistrup C, Thiesson HC, Søndergaard E, Hamilton-Dutoit S, Jespersen B. Post-transplant lymphoproliferative disorder following kidney transplantation: a population-based cohort study. Transpl Int. 2016 Apr;29(4):483-93. doi: 10.1111/tri.12744. Epub 2016 Feb 18.
- San-Juan R, Manuel O, Hirsch HH, Fernández-Ruiz M, López-Medrano F, Comoli P, Caillard S, Grossi P, Aguado JM; ESGICH PTLD Survey Study Group,; European Study Group of Infections in Compromised Hosts (ESGICH) from the European Society of Microbiology and Infectious Diseases (ESCMID). Current preventive strategies and management of Epstein-Barr virus-related post-transplant lymphoproliferative disease in solid organ transplantation in Europe. Results of the ESGICH Questionnaire-based Cross-sectional Survey. Clin Microbiol Infect. 2015 Jun;21(6):604.e1-9. doi: 10.1016/j.cmi.2015.02.002. Epub 2015 Feb 14.
- EBV-KMA
- 1-16-02-685-16