ClinicalTrials.gg
Active, not recruitingNCT06444152Updated Jan 30, 2026

Prevalence of Epstein-Barr Virus Infection

An observational study in Lymph Node Excision Biopsy, sponsored by University of Pennsylvania. Active, not recruiting at 1 site in Botswana. Per ClinicalTrials.gov, last updated 2026-01-30.

Sponsored by University of Pennsylvania · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Sex
All
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Study summary

This will be a cross sectional, pilot study to determine the burden of EBV related lymphomas in this population. Patient information including demographics and HIV status, history of HIV infection, HIV viral load and CD4 counts and ART history will be retrieved from the integrated patient management system (IPMS) Lymph node excision biopsy samples, collected at NHL between 2012 and 2017, from the patient with a diagnosis of lymphoma will be retrieved using IPMS from National Health Laboratory and analyzed by immunohistochemistry.

Read the detailed description

Lymph node excision biopsy samples,which have been formalin fixed and paraffin embedded, of 50 HIV-infected and 50 HIV-uninfected patients from the patient with a diagnosis of lymphoma, will be retrieved using IPMS from National Health Laboratory. Archived diagnostic biopsy material will be collected from NHL between 2012 and 2017 (5 years). They will be analyzed by immunohistochemistry using LMP-1/EBNA1/ENNA2 staining, either alone or combined which indicates a diagnosis of EBV infection.

We will compute rates of EBV associated lymphomas among HIV infected and HIV uninfected individuals using descriptive statistics. The students t-test will be used for continuous variables while the Pearson's chi squared test (or Fisher's exact test where appropriate) will be used to compare categorical variables. Significance will be assigned for P values of 0.05 or less

02

Conditions studied

  • Lymph Node Excision Biopsy
03

In context

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Formalin fixed paraffin embedded tissue (FFPE) of lymph node excision biopsy samples from the patient with a diagnosis of lymphoma

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All available lymph node samples with a diagnosis of lymphoma and complete data of status, HIV viral load and and ART history will be retrieved from IPMS.

Exclusion criteria

Exclusion Criteria:

  • Samples with incomplete data
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No

Interventions

  • OtherSample analysis

    This study is analyzing stored samples

06

What researchers measure

Primary outcomes

  1. Burden of EBV

    The prevalence of EBV associated lymphomas among HIV-infected and HIV-uninfected patients in excision biopsy specimens of lymph nodes. This will be a cross sectional, pilot study to determine the burden of EBV related lymphomas in this population.

    Time frame: 12 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2023 (actual). Primary completion is estimated for Dec 2027, 52 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 29, 2024
First posted
Jun 5, 2024
StartActual
Aug 1, 2023
Primary completionEst.
Dec 20, 2027
CompletionEst.
Dec 20, 2027
Last update
Jan 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06444152
Collaborators
University of Botswana
Responsible party
Sponsor
First posted
Jun 5, 2024
Start date
Aug 1, 2023
Primary completion
Dec 20, 2027 (estimated)
Completion
Dec 20, 2027 (estimated)
Last update
Jan 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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