Viewing Study NCT06444152



Ignite Creation Date: 2024-06-16 @ 11:50 AM
Last Modification Date: 2024-10-26 @ 3:31 PM
Study NCT ID: NCT06444152
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-06-05
First Post: 2024-05-29

Brief Title: Prevalence of Epstein-Barr Virus Infection
Sponsor: University of Pennsylvania
Organization: University of Pennsylvania

Study Overview

Official Title: Prevalence of Epstein-Barr Virus Infection in HIV Infected and HIV Uninfected Patients Presenting With Lymphomas in Botswana
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 sampleswhich 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-1EBNA1ENNA2 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 Pearsons chi squared test or Fishers exact test where appropriate will be used to compare categorical variables Significance will be assigned for P values of 005 or less

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None