HIV, Kaposi Sarcoma Herpesvirus -Associated Multicentric Castleman Disease, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Tiny Isothermal Nucleic Acid Amplification System, Lymphadenopathy
Conditions
Keywords
Sub-Saharan Africa
Brief 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.
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.
Interventions
PROCEDURELymph Node or Core Needle Biopsy
DNA isolation to be tested by nucleic acid amplification using the TINY device
PROCEDUREFine Needle Aspiration
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.
DIAGNOSTIC_TESTTiny Isothermal Nucleic acid Amplification System (TINY)
Tiny Isothermal Nucleic acid Amplification System (TINY)
Sponsors
Indiana University
UNC Lineberger Comprehensive Cancer Center
National Institutes of Health (NIH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with diagnoses | Enrollment | Proportion of patients diagnosed with each of the following by histopathology and immunohistochemistry: tuberculosis, lymphoma, MCD, other diagnosis, or non-diagnostic. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline clinical and laboratory characteristics | Enrollment | HIV viral load (the number of copies of HIV RNA per milliliter of blood plasma, copies/mL) |
| Diagnostic performance of KSHV DNA quantification using TINY | Enrollment | Using lymph node fine needle aspiration (FNA) and tissue biopsy samples using TINY for the diagnosis of KSHV |
| Diagnostic performance of EBV DNA quantification using TINY | Enrollment | Using lymph node fine needle aspiration (FNA) and tissue biopsy using TINY for the diagnosis of EBV |
| Performance of KSHV DNA quantification using TINY | Enrollment | Using a peripheral blood sample using TINY for the diagnosis of KSHV |
| Performance of EBV DNA quantification using TINY | Enrollment | Using peripheral blood sample using TINY for the diagnosis of EBV |
Countries
Malawi
Contacts
CONTACTMatthew Painschab, MD
CONTACTYuri Fedoriw, MD
PRINCIPAL_INVESTIGATORMichael Painschab, MD
IUSCCC
Outcome results
None listed