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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Approaches for the Diagnosis of Lymphoma and Multicentric Castleman Disease
- ClinicalTrials.gov ID
- NCT07793006
- Acronym / sponsor ID
- IUSCCC2308
- Conditions
- HIV, Kaposi Sarcoma Herpesvirus -Associated Multicentric Castleman Disease, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Tiny Isothermal Nucleic Acid Amplification System, Lymphadenopathy
- Keywords
- Sub-Saharan Africa
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- UNC Lineberger Comprehensive Cancer Center, National Institutes of Health (NIH)
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-infected patients with unexplained lymphadenopathy | Experimental | Procedure: Lymph Node or Core Needle Biopsy, Procedure: Fine Needle Aspiration, Diagnostic Test: Tiny Isothermal Nucleic acid Amplification System (TINY)HIV-infected patients in routine clinical care with unexplained lymphadenopathy |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lymph Node or Core Needle BiopsyDNA isolation to be tested by nucleic acid amplification using the TINY device | Procedure or surgery | HIV-infected patients with unexplained lymphadenopathy |
| Fine Needle AspirationThe 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. | Procedure or surgery | HIV-infected patients with unexplained lymphadenopathy |
| Tiny Isothermal Nucleic acid Amplification System (TINY)Tiny Isothermal Nucleic acid Amplification System (TINY) | Diagnostic test | HIV-infected patients with unexplained lymphadenopathy |
Primary outcome
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.
10 secondary outcomes
Baseline clinical and laboratory characteristics
Time frame: Enrollment
Baseline clinical and laboratory characteristics
Time frame: Enrollment
Baseline clinical and laboratory characteristics
Time frame: Enrollment
Baseline clinical and laboratory characteristics
Time frame: Enrollment
Baseline clinical and laboratory characteristics
Time frame: Enrollment
Baseline clinical and laboratory characteristics
Time frame: Enrollment
Diagnostic performance of KSHV DNA quantification using TINY
Time frame: Enrollment
Diagnostic performance of EBV DNA quantification using TINY
Time frame: Enrollment
Performance of KSHV DNA quantification using TINY
Time frame: Enrollment
Performance of EBV DNA quantification using TINY
Time frame: Enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Painschab, MD principal investigator
IUSCCC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Painschab, MD ((317) 278-0626, mapain@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with diagnoses (time frame: Enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.