Early Detection of Epstein-Barr Virus Related Disease.
2 other identifiers
observational
1,527
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 7, 2018
CompletedFirst Posted
Study publicly available on registry
June 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedOctober 31, 2023
December 1, 2022
1.3 years
May 7, 2018
October 27, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of proven EBV disease
Symptoms compatible with EBV disease combined with a tissue biopsy positive for EBV
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
From time of blood sampling up to 24 months.
Study Arms (3)
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.
Eligibility Criteria
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.
You may qualify if:
- Patients suspected for having EBV disease.
You may not qualify if:
- If the patients has any contraindications for blood sampling.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aarhus University Hospitalcollaborator
Study Sites (1)
Aarhus University Hospital
Aarhus, Central Region of Denmark, 8200, Denmark
Related Publications (1)
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.
PMID: 37683299RESULT
Biospecimen
Blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lene Ugilt, MD
University of Aarhus
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2018
First Posted
June 6, 2018
Study Start
November 1, 2017
Primary Completion
March 1, 2019
Study Completion
May 1, 2023
Last Updated
October 31, 2023
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share