Prevalence of Epstein-Barr Virus Infection

Active, not recruiting

• Conditions: Lymph Node Excision Biopsy

• Registration Number: NCT06444152
• Lead Sponsor: University of Pennsylvania

Brief 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.

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

Study Timeline

• Study Start: 2023-08-01
• Study First Submitted: 2024-05-29
• Study First Submitted QC: 2024-06-04
• Study First Posted: 2024-06-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-12-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All available lymph node biopsy samples with a diagnosis of lymphoma and complete data of HIV status, HIV viral load and CD4 counts and ART history will be retrieved from IPMS.

Exclusion Criteria

• Samples with incomplete data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Burden of EBV	12 months	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.

Trial Locations

Locations (1)

University of Botswana; 🇧🇼 Gaborone, Botswana