HIVNCT07793006
New Approaches for the Diagnosis of Lymphoma and Multicentric Castleman Disease
A study testing Lymph Node or Core Needle Biopsy, Fine Needle Aspiration and Tiny Isothermal Nucleic acid Amplification System (TINY) in people with HIV and Kaposi Sarcoma Herpesvirus -Associated Multicentric Castleman Disease, run by Indiana University at 1 site in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- HIV, Kaposi Sarcoma Herpesvirus -Associated Multicentric Castleman Disease, Hodgkin Lymphoma
- What is being tested?
- Lymph Node or Core Needle Biopsy, Fine Needle Aspiration and Tiny Isothermal Nucleic acid Amplification System (TINY)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteMalawi
- Study dates
- 17 Mar 2025to Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malawi1 site, 1 recruiting
- Recruiting
Lighthouse Trust HIV Centers of Excellence
Lilongwe
Shiraz Khan, MBBS, 265 999760776, skhan@unclilongwe.org
About this study
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.
Read the detailed description
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.
- Conditions
- HIV, Kaposi Sarcoma Herpesvirus -Associated Multicentric Castleman Disease, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Tiny Isothermal Nucleic Acid Amplification System, Lymphadenopathy
- Being tested
- Lymph Node or Core Needle Biopsy, Fine Needle Aspiration, Tiny Isothermal Nucleic acid Amplification System (TINY)
- Keywords
- Sub-Saharan Africa
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin, Lymphadenopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymph Node or Core Needle BiopsyProcedure or surgery
DNA isolation to be tested by nucleic acid amplification using the TINY device
Fine Needle AspirationProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| HIV-infected patients with unexplained lymphadenopathy | Experimental | HIV-infected patients in routine clinical care with unexplained lymphadenopathy Receives: Procedure: Lymph Node or Core Needle Biopsy; Procedure: Fine Needle Aspiration; Diagnostic Test: Tiny Isothermal Nucleic acid Amplification System (TINY) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Enrollment
Secondary outcomes (10)
Baseline clinical and laboratory characteristics
HIV viral load (the number of copies of HIV RNA per milliliter of blood plasma, copies/mL)
Measured: Enrollment
Baseline clinical and laboratory characteristics
CD4 count
Measured: Enrollment
Baseline clinical and laboratory characteristics
complete blood count
Measured: Enrollment
Baseline clinical and laboratory characteristics
creatinine and liver panel
Measured: Enrollment
Baseline clinical and laboratory characteristics
plasma storage
Measured: Enrollment
Baseline clinical and laboratory characteristics
buffy coat storage
Measured: Enrollment
Diagnostic performance of KSHV DNA quantification using TINY
Using lymph node fine needle aspiration (FNA) and tissue biopsy samples using TINY for the diagnosis of KSHV
Measured: Enrollment
Diagnostic performance of EBV DNA quantification using TINY
Using lymph node fine needle aspiration (FNA) and tissue biopsy using TINY for the diagnosis of EBV
Measured: Enrollment
Performance of KSHV DNA quantification using TINY
Using a peripheral blood sample using TINY for the diagnosis of KSHV
Measured: Enrollment
Performance of EBV DNA quantification using TINY
Using peripheral blood sample using TINY for the diagnosis of EBV
Measured: Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start17 Mar 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- UNC Lineberger Comprehensive Cancer Center, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Matthew Painschab, Indiana University
- Investigators
- Michael Painschab, MD, Principal investigator, IUSCCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793006
- Sponsor's protocol ID
- IUSCCC2308
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes