ClinicalTrials.gov record NCT07793006

New Approaches for the Diagnosis of Lymphoma and Multicentric Castleman Disease

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 5, 2026

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

Age1 year old and older

SexAll

LocationMalawi

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This interventional diagnostic study evaluates the Tiny Isothermal Nucleic acid Amplification System (TINY) for detecting viral DNA linked to lymphoma and multicentric Castleman disease. It enrolls people living with HIV who have unexplained lymphadenopathy. Participants provide lymph node fine-needle aspiration or core-needle biopsy samples and blood; samples are tested with TINY and compared with other laboratory and pathology tests.

What it is studying. The study tests whether the TINY nucleic-acid assay can detect Epstein-Barr virus (EBV) and Kaposi sarcoma herpesvirus (KSHV) DNA in lymph node and blood samples, and measures its diagnostic performance compared with histopathology, immunohistochemistry, and other tests.

What the researchers hope to learn. To assess the diagnostic performance of the TINY nucleic-acid assay for detecting KSHV and EBV in lymph node and blood samples; to document diagnoses by histopathology and immunohistochemistry in people with HIV and lymphadenopathy; and to collect baseline clinical and laboratory data and stored plasma/buffy coat samples for analysis.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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 being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

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

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You would undergo a lymph node biopsy or core‑needle biopsy and a fine needle aspiration (FNA) of the enlarged lymph node — these are the main invasive procedures in the study. Biopsy and FNA samples will be tested using the Tiny Isothermal Nucleic Acid Amplification System (TINY) for Epstein‑Barr virus (EBV) and Kaposi sarcoma herpesvirus (KSHV); one FNA sample will also be used for Gene Xpert. Blood will be drawn for baseline clinical tests (HIV viral load, CD4 count, complete blood count, kidney and liver tests), for TINY testing of EBV/KSHV in blood, and for storage of plasma and buffy coat for later testing.

How the study is structured. Interventional diagnostic study with a single participant group and no masking. Enrolled participants receive a lymph node fine-needle aspiration or a lymph node/core biopsy and provide peripheral blood. Samples are analyzed with the TINY device for EBV and KSHV; some samples are also tested by GeneXpert and qPCR and examined by histopathology and immunohistochemistry. Primary outcome is the number and types of diagnoses established by pathology (tuberculosis, lymphoma, MCD, other, or non-diagnostic); secondary outcomes include measures of diagnostic performance and baseline laboratory characteristics.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The listed sites are in Malawi. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on Castleman disease

Clinical trials14 trials listed for Castleman diseaseEvery trial the registry lists for Castleman disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Castleman disease researchLatest monthly update: September 2026. Includes: Unicentric tumor removal. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Mar 17, 2025
Primary completion: December 2028 (estimated)
Study completion: December 2028 (estimated)
Target enrollment: 500 participants (estimated)
Last updated on registry: Aug 28, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Indiana University
Principal investigator: Matthew Painschab, Associate Professor of Medicine
Indiana University
Collaborators: UNC Lineberger Comprehensive Cancer Center
National Institutes of Health (NIH)

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Matthew Painschab, MD 📞 (317) 278-0626 ✉ mapain@iu.edu
Yuri Fedoriw, MD 📞 1 984-974-8320 ✉ Yuri.Fedoriw@unchealth.unc.edu

Participating sites (1)

Lighthouse Trust HIV Centers of ExcellenceRecruiting
Lilongwe · Malawi
- Shiraz Khan, MBBS · 265 999760776 · skhan@unclilongwe.org

Terms used on this page · explanations by MedicalUpdates.ai

biopsy: Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
assent: A child's or dependent adult's agreement to take part, given alongside the formal consent of a parent or legal representative.
legal guardian: A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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