New Approaches for the Diagnosis of Lymphoma and Multicentric Castleman Disease

Sponsor
Indiana University
Study ID
NCT07793006
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lymph Node or Core Needle Biopsy — PROCEDURE
    DNA isolation to be tested by nucleic acid amplification using the TINY device
  • 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.
  • Tiny Isothermal Nucleic acid Amplification System (TINY) — DIAGNOSTIC_TEST
    Tiny Isothermal Nucleic acid Amplification System (TINY)

Study Details

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.

Key Dates

First listed
Aug 28, 2026
Start date
Mar 17, 2025
Status verified
Aug 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: HIV-infected patients with unexplained lymphadenopathy
    HIV-infected patients in routine clinical care with unexplained lymphadenopathy

Primary Outcome Measure

Number of patients with diagnoses [ Time Frame: Enrollment ]

Central Contacts

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