New Approaches for the Diagnosis of Lymphoma and Multicentric Castleman Disease

Indiana University500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

500

Conditions

HIV Kaposi Sarcoma Herpesvirus -Associated Multicentric Castleman Disease

Interventions

Lymph Node or Core Needle BiopsyPROCEDURE

DNA isolation to be tested by nucleic acid amplification using the TINY device

Fine Needle AspirationPROCEDURE

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)

Eligibility

Sex: ALLMin age: 1 Year

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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