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RECRUITING Not applicable ClinicalTrials.gov

New Approaches for the Diagnosis of Lymphoma and Multicentric Castleman Disease

Sponsor: Indiana University • ClinicalTrials.gov ID: NCT07793006

Registry updated: 2026-08-28
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Description

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.

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)

Eligibility criteria

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).

Conditions

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

Locations

  • Lighthouse Trust HIV Centers of Excellence — Lilongwe, Malawi
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record