Post-transplant Lymphoproliferative DisorderNCT03546101
Early Detection of Epstein-Barr Virus Related Disease.
An observational study of Post-transplant Lymphoproliferative Disorder and Mononucleosis, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post-transplant Lymphoproliferative Disorder, Mononucleosis, Epstein-Barr Virus Infections
- How many people
- 1,527 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2017to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients suspected for having EBV disease.
Who cannot join
- If the patients has any contraindications for blood sampling.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital
Aarhus, Central Region of Denmark, 8200
About this study
Official title: Early Detection of Epstein-Barr Virus Related Disease. Improving Quantification of EBV in Blood Samples Using Polymerase Chain Reaction.
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.
Read the 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.
- Conditions
- Post-transplant Lymphoproliferative Disorder, Mononucleosis, Epstein-Barr Virus Infections, Epstein-Barr Virus Related Malignancy, Epstein-Barr Viraemia, Epstein-Barr Virus-Related Hodgkin Lymphoma
- Medical subject headings
- Infectious Mononucleosis, Epstein-Barr Virus Infections, Lymphohistiocytosis, Hemophagocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of proven EBV disease
Symptoms compatible with EBV disease combined with a tissue biopsy positive for EBV
Measured: 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
Measured: From time of blood sampling up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start1 Nov 2017
- Primary completion1 Mar 2019
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-transplant Lymphoproliferative DisorderStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,527 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Lene Ugilt, MD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546101
- Sponsor's protocol ID
- EBV-KMA
- Other IDs
- 1-16-02-685-16
- Status last verified
- Dec 2022
- First submitted
- 7 May 2018
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37683299
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Epstein-Barr Virus Related Disease. Improving Quantification of EBV in Blood Samples Using Polymerase Chain Reaction.
- ClinicalTrials.gov ID
- NCT03546101
- Acronym / sponsor ID
- EBV-KMA
- Conditions
- Post-transplant Lymphoproliferative Disorder, Mononucleosis, Epstein-Barr Virus Infections, Epstein-Barr Virus Related Malignancy, Epstein-Barr Viraemia, Epstein-Barr Virus-Related Hodgkin Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,527 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients suspected for having EBV disease.
Key exclusion criteria (1 listed)
- If the patients has any contraindications for blood sampling.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Results publication: PubMed 37683299Ludvigsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lene Ugilt, MD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-transplant Lymphoproliferative Disorder and Mononucleosis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of proven EBV disease (time frame: From time of blood sampling up to 24 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03546101, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.