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Early Detection of Epstein-Barr Virus Related Disease.

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ClinicalTrials.gov Identifier: NCT03546101
Recruitment Status : Active, not recruiting
First Posted : June 5, 2018
Last Update Posted : October 22, 2019
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
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.


Condition or disease
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

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.


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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Detection of Epstein-Barr Virus Related Disease. Improving Quantification of EBV in Blood Samples Using Polymerase Chain Reaction.
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022


Group/Cohort
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.



Primary Outcome Measures :
  1. Incidence of proven EBV disease [ Time Frame: From time of blood sampling up to 24 months. ]
    Symptoms compatible with EBV disease combined with a tissue biopsy positive for EBV

  2. Incidence of probable EBV disease [ Time Frame: From time of blood sampling up to 24 months. ]
    Symptoms compatible with EBV disease combined with a positive EBV-PCR


Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • Patients suspected for having EBV disease.

Exclusion Criteria:

  • If the patients has any contraindications for blood sampling.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546101


Locations
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Denmark
Aarhus University Hospital
Aarhus, Central Region Of Denmark, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
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Principal Investigator: Lene Ugilt, MD University of Aarhus

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

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03546101     History of Changes
Other Study ID Numbers: EBV-KMA
1-16-02-685-16 ( Other Identifier: The Danish Data Protection Agency )
First Posted: June 5, 2018    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pathologic Processes
Histiocytosis, Non-Langerhans-Cell
Viremia
Epstein-Barr Virus Infections
Lymphoma
Lymphoproliferative Disorders
Lymphohistiocytosis, Hemophagocytic
Virus Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Histiocytosis
Herpesviridae Infections
DNA Virus Infections
Tumor Virus Infections