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
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
- HIV
- Kaposi Sarcoma Herpesvirus -Associated Multicentric Castleman Disease
- Hodgkin Lymphoma
- Non-Hodgkin Lymphoma
- Tiny Isothermal Nucleic Acid Amplification System
- Lymphadenopathy
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
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