New ways to diagnose lymphoma and multicentric Castleman disease in people living with HIV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers are evaluating a nucleic acid–based assay that can be used at the point of care to detect disease-causing signals from biopsy or fine-needle samples. The test uses the Tiny Isothermal Nucleic acid Amplification System (TINY) with EBV markers, leveraging knowledge that KSHV is highly sensitive for diagnosing MCD. The study involves lymph node or core needle biopsies, fine-needle aspiration, and TINY analysis to distinguish lymphoma and MCD in HIV-infected individuals. Enrollment includes adults and children with unexplained lymphadenopathy amenable to biopsy in SSA, with appropriate consent procedures. The goal is to shorten diagnostic delays and improve accuracy in resource-limited settings.

Why it matters

Who can join: the full rules

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).

Where it's running

• Lighthouse Trust HIV Centers of Excellence
  Lilongwe, Malawi Recruiting

Study contacts

• Principal investigator: Michael Painschab, MD — Iusccc
• Study coordinator: Matthew Painschab, MD
• Email: mapain@iu.edu
• Phone: (317) 278-0626

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.