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New Approaches for the Diagnosis of Lymphoma and Multicentric Castleman Disease

ConditionsHIVKaposi Sarcoma Herpesvirus -Associated Multicentric Castleman DiseaseHodgkin LymphomaNon-Hodgkin LymphomaTiny Isothermal Nucleic Acid Amplification SystemLymphadenopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1+
SponsorIndiana University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Lymph Node or Core Needle Biopsy

    Procedure/Surgery

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

  • Fine Needle Aspiration

    Procedure/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)

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: HIV-infected patients with unexplained lymphadenopathyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Baseline clinical and laboratory characteristics

CD4 count

Time frame
Enrollment
3

Baseline clinical and laboratory characteristics

complete blood count

Time frame
Enrollment
4

Baseline clinical and laboratory characteristics

creatinine and liver panel

Time frame
Enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborator

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov
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