An interventional study of Lymph Node or Core Needle Biopsy and Fine Needle Aspiration in HIV, Kaposi Sarcoma Herpesvirus -Associated Multicentric Castleman Disease and Hodgkin Lymphoma, sponsored by Indiana University. Recruiting at 1 site in Malawi. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Indiana University · Not applicable, Interventional, and Diagnostic
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.
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.
1,383 studies on the registry are indexed under Hodgkin Disease; 163 are open to participants now.
This study's planned enrollment of 500 is above the median of 40 across 1,095 interventional studies indexed under Hodgkin Disease.
Browse Hodgkin Disease studies →Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV-infected patients in routine clinical care with unexplained lymphadenopathy
Procedure: Lymph Node or Core Needle Biopsy · Procedure: Fine Needle Aspiration · Diagnostic Test: Tiny Isothermal Nucleic acid Amplification System (TINY)
DNA isolation to be tested by nucleic acid amplification using the TINY device
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)
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.
Time frame: Enrollment
Baseline clinical and laboratory characteristics
HIV viral load (the number of copies of HIV RNA per milliliter of blood plasma, copies/mL)
Time frame: Enrollment
Baseline clinical and laboratory characteristics
CD4 count
Time frame: Enrollment
Baseline clinical and laboratory characteristics
complete blood count
Time frame: Enrollment
Baseline clinical and laboratory characteristics
creatinine and liver panel
Time frame: Enrollment
Baseline clinical and laboratory characteristics
plasma storage
Time frame: Enrollment
Baseline clinical and laboratory characteristics
buffy coat storage
Time frame: 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
Time frame: 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
Time frame: Enrollment
Performance of KSHV DNA quantification using TINY
Using a peripheral blood sample using TINY for the diagnosis of KSHV
Time frame: Enrollment
Performance of EBV DNA quantification using TINY
Using peripheral blood sample using TINY for the diagnosis of EBV
Time frame: Enrollment
Started Mar 2025 (actual). Primary completion is estimated for Dec 2028, 45 months after the start.
Of 49 non-industry interventional studies with no phase under Hodgkin Disease, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 128. This study's planned 45 months is close to that.
Counting every sponsor, half of 52 studies reached it within 43 months; a quarter within 29 and three quarters within 128.
How these figures are worked out, and which studies are left out of them.
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