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NCT Number: NCT07793006

New Approaches for the Diagnosis of Lymphoma and Multicentric Castleman Disease

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.

Recruiting

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Key information

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lighthouse Trust HIV Centers of Excellence

Lilongwe, Malawi

Location status: Recruiting

Location contact

Shiraz Khan, MBBS

CONTACT

[email protected]

265 999760776

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. Baseline clinical and laboratory characteristics

    Time frame: Enrollment

    CD4 count

  3. Baseline clinical and laboratory characteristics

    Time frame: Enrollment

    complete blood count

  4. Baseline clinical and laboratory characteristics

    Time frame: Enrollment

    creatinine and liver panel

  5. Baseline clinical and laboratory characteristics

    Time frame: Enrollment

    plasma storage

  6. Baseline clinical and laboratory characteristics

    Time frame: Enrollment

    buffy coat storage

  7. 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

  8. 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

  9. Performance of KSHV DNA quantification using TINY

    Time frame: Enrollment

    Using a peripheral blood sample using TINY for the diagnosis of KSHV

  10. Performance of EBV DNA quantification using TINY

    Time frame: Enrollment

    Using peripheral blood sample using TINY for the diagnosis of EBV

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Painschab, MD

CONTACT

[email protected]

(317) 278-0626

Yuri Fedoriw, MD

CONTACT

[email protected]

1 984-974-8320

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

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

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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