Lighthouse Trust HIV Centers of Excellence
Lilongwe, Malawi
Location status: Recruiting
NCT Number: NCT07793006
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.
Interested in participating?
Request Info1 year and older
All sexes
Interventional
Not applicable
Lilongwe, Malawi
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: Enrollment
Proportion of patients diagnosed with each of the following by histopathology and immunohistochemistry: tuberculosis, lymphoma, MCD, other diagnosis, or non-diagnostic.
Time frame: Enrollment
HIV viral load (the number of copies of HIV RNA per milliliter of blood plasma, copies/mL)
Time frame: Enrollment
CD4 count
Time frame: Enrollment
complete blood count
Time frame: Enrollment
creatinine and liver panel
Time frame: Enrollment
plasma storage
Time frame: Enrollment
buffy coat storage
Time frame: Enrollment
Using lymph node fine needle aspiration (FNA) and tissue biopsy samples using TINY for the diagnosis of KSHV
Time frame: Enrollment
Using lymph node fine needle aspiration (FNA) and tissue biopsy using TINY for the diagnosis of EBV
Time frame: Enrollment
Using a peripheral blood sample using TINY for the diagnosis of KSHV
Time frame: Enrollment
Using peripheral blood sample using TINY for the diagnosis of EBV
Contact information is provided by the study sponsor or research team.
Matthew Painschab, MD
CONTACT
Yuri Fedoriw, MD
CONTACT
Indiana University
Other
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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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