An observational study in Post-transplant Lymphoproliferative Disorder, Mononucleosis and Epstein-Barr Virus Infections, sponsored by University of Aarhus. Completed at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2023-10-31.
Sponsored by University of Aarhus · Observational
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.
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.
21 studies on the registry are indexed under Infectious Mononucleosis; 5 are open to participants now.
This study's enrollment of 1,527 is above the median of 200 across 11 observational studies indexed under Infectious Mononucleosis.
Browse Infectious Mononucleosis studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
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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.
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Primarily transplant recipients undergoing monitoring for EBV and patients suspected for having PTLD.
Patients diagnosed with PTLD and other kinds of lymphoma. Patients undergoing hematopoietic stem cell transplantation and patients with hemophagocytosis.
Children undergoing transplantation. Children diagnosed with hemophagocytic lymphohistiocytosis.
Incidence of proven EBV disease
Symptoms compatible with EBV disease combined with a tissue biopsy positive for EBV
Time frame: From time of blood sampling up to 24 months.
Incidence of probable EBV disease
Symptoms compatible with EBV disease combined with a positive EBV-PCR
Time frame: From time of blood sampling up to 24 months.
Plan to share: No
Ran from Nov 2017 to primary completion in Mar 2019, 16 months.
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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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