New Approaches for the Diagnosis of Lymphoma and Multicentric Castleman Disease

NCT07793006 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-08-28

No results posted yet for this study

Summary

Persons living with HIV (PLWH) in sub-Saharan Africa (SSA), lymphadenopathy often portends one of a number of life-threatening diseases including tuberculosis, lymphoma, and multicentric Castleman disease (MCD). Overcoming these delays and missed diagnoses requires new approaches to identify lymphoma and MCD.

Conditions

Interventions

PROCEDURE

Lymph Node or Core Needle Biopsy

DNA isolation to be tested by nucleic acid amplification using the TINY device

PROCEDURE

Fine Needle Aspiration

The sample will be eluted into two tubes, one for Gene Xpert testing and one for storage for EBV and KSHV testing by qPCR and TINY.

DIAGNOSTIC_TEST

Tiny Isothermal Nucleic acid Amplification System (TINY)

Tiny Isothermal Nucleic acid Amplification System (TINY)

Sponsors & Collaborators

  • UNC Lineberger Comprehensive Cancer Center

    collaborator OTHER
  • National Institutes of Health (NIH)

    collaborator NIH
  • Indiana University

    lead OTHER

Principal Investigators

  • Michael Painschab, MD · IUSCCC

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-17
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • Malawi

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07793006 on ClinicalTrials.gov