New Approaches for the Diagnosis of Lymphoma and Multicentric Castleman Disease

August 25, 2026 updated by: Matthew Painschab, Indiana University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To address the need for new approaches to diagnose lymphoma and multicentric Castleman disease (MCD), investigators have developed an assay based on nucleic acid measurement that has the potential to be delivered at the point of clinical care. It has demonstrated the ability to detect Epstein-Barr virus (EBV) from fine needle aspirations (FNA) and from tumor cells using the Tiny Isothermal Nucleic acid Amplification System (TINY) device, employing primers for EBV-encoded small RNAs (EBER). The method takes advantage of the now well-established finding that Kaposi sarcoma herpesvirus (KSHV) is nearly entirely sensitive (though not specific) for the diagnosis of MCD.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Matthew Painschab, MD
  • Phone Number: (317) 278-0626
  • Email: mapain@iu.edu

Study Contact Backup

Study Locations

  • Malawi
      • Lilongwe, Malawi
        • Recruiting
        • Lighthouse Trust HIV Centers of Excellence
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥1 year old and body weight of ≥ 10 kg.
  • HIV-infected.
  • Unexplained lymphadenopathy with at least one lymph node ≥2 cm that is amenable to biopsy.
  • Willing and able to give informed consent if the subject is 18 years of age or older, adolescent assent and legal guardian consent for subjects 15-17 years of age, pediatric assent and legal guardian consent for subjects 7-14 years of age, or legal guardian consent for pediatric subjects less than 7 years of age.

Exclusion Criteria:

  • Cannot or is not willing to follow study procedures.
  • Subjects with a previous history of cancer in the last five years with the exception of subjects with Kaposi sarcoma (i.e. history of Kaposi sarcoma is allowed in the study).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HIV-infected patients with unexplained lymphadenopathy
HIV-infected patients in routine clinical care with unexplained lymphadenopathy
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with diagnoses
Time Frame: Enrollment
Proportion of patients diagnosed with each of the following by histopathology and immunohistochemistry: tuberculosis, lymphoma, MCD, other diagnosis, or non-diagnostic.
Enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline clinical and laboratory characteristics
Time Frame: Enrollment
HIV viral load (the number of copies of HIV RNA per milliliter of blood plasma, copies/mL)
Enrollment
Baseline clinical and laboratory characteristics
Time Frame: Enrollment
CD4 count
Enrollment
Baseline clinical and laboratory characteristics
Time Frame: Enrollment
complete blood count
Enrollment
Baseline clinical and laboratory characteristics
Time Frame: Enrollment
creatinine and liver panel
Enrollment
Baseline clinical and laboratory characteristics
Time Frame: Enrollment
plasma storage
Enrollment
Baseline clinical and laboratory characteristics
Time Frame: Enrollment
buffy coat storage
Enrollment
Diagnostic performance of KSHV DNA quantification using TINY
Time Frame: Enrollment
Using lymph node fine needle aspiration (FNA) and tissue biopsy samples using TINY for the diagnosis of KSHV
Enrollment
Diagnostic performance of EBV DNA quantification using TINY
Time Frame: Enrollment
Using lymph node fine needle aspiration (FNA) and tissue biopsy using TINY for the diagnosis of EBV
Enrollment
Performance of KSHV DNA quantification using TINY
Time Frame: Enrollment
Using a peripheral blood sample using TINY for the diagnosis of KSHV
Enrollment
Performance of EBV DNA quantification using TINY
Time Frame: Enrollment
Using peripheral blood sample using TINY for the diagnosis of EBV
Enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

National Institutes of Health (NIH)
UNC Lineberger Comprehensive Cancer Center

Investigators

  • Principal Investigator: Michael Painschab, MD, IUSCCC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

July 17, 2026

First Submitted That Met QC Criteria

August 25, 2026

First Posted (Actual)

August 28, 2026

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 25, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUSCCC2308

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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