NCT06444152

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Aug 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Aug 2023Dec 2027

Study Start

First participant enrolled

August 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2027

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

4.4 years

First QC Date

May 29, 2024

Last Update Submit

January 28, 2026

Conditions

Lymph Node Excision Biopsy

Outcome Measures

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.

    12 months

Interventions

Sample analysisOTHER

This study is analyzing stored samples

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Samples with incomplete data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Botswana

Gaborone, 267, Botswana

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2024

First Posted

June 5, 2024

Study Start

August 1, 2023

Primary Completion (Estimated)

December 20, 2027

Study Completion (Estimated)

December 20, 2027

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

BO(1)