New Approaches for the Diagnosis of Lymphoma and Multicentric Castleman Disease

NCT07793006 | Recruiting DMC FDA Device

• 1 other identifier: IUSCCC2308
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sub-Saharan Africa

Outcome Measures

Primary Outcomes (1)

• Number of patients with diagnoses

  Proportion of patients diagnosed with each of the following by histopathology and immunohistochemistry: tuberculosis, lymphoma, MCD, other diagnosis, or non-diagnostic.

  Enrollment

Secondary Outcomes (10)

• Baseline clinical and laboratory characteristics

  Enrollment

• Baseline clinical and laboratory characteristics

  Enrollment

• Baseline clinical and laboratory characteristics

  Enrollment

• Baseline clinical and laboratory characteristics

  Enrollment

• Baseline clinical and laboratory characteristics

  Enrollment

Study Arms (1)

HIV-infected patients with unexplained lymphadenopathy

EXPERIMENTAL

HIV-infected patients in routine clinical care with unexplained lymphadenopathy

Procedure: Lymph Node or Core Needle Biopsy; Procedure: Fine Needle Aspiration; Diagnostic Test: Tiny Isothermal Nucleic acid Amplification System (TINY)

Interventions

Lymph Node or Core Needle Biopsy PROCEDURE

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

HIV-infected patients with unexplained lymphadenopathy

Fine Needle Aspiration PROCEDURE

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.

HIV-infected patients with unexplained lymphadenopathy

Tiny Isothermal Nucleic acid Amplification System (TINY) DIAGNOSTIC_TEST

Tiny Isothermal Nucleic acid Amplification System (TINY)

HIV-infected patients with unexplained lymphadenopathy

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Indiana University: lead
• UNC Lineberger Comprehensive Cancer Center: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Lighthouse Trust HIV Centers of Excellence

Lilongwe, Malawi

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Non-Hodgkin; Lymphadenopathy

Interventions

Biopsy, Large-Core Needle; Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• Michael Painschab, MD

  IUSCCC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Painschab, MD

CONTACT

(317) 278-0626; mapain@iu.edu

Yuri Fedoriw, MD

CONTACT

1 984-974-8320; Yuri.Fedoriw@unchealth.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: August 28, 2026
• Study Start: March 17, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

MA (1)