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Can a tiny device speed up cancer diagnosis for people with HIV?

NCT ID NCT07793006

Diagnosis Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This study tests new diagnostic approaches for lymphoma and multicentric Castleman disease in people living with HIV who have swollen lymph nodes. Researchers will compare standard biopsies with fine needle aspiration and a new nucleic acid amplification device called TINY. The goal is to see if these methods can accurately identify these life-threatening conditions faster and less invasively.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lymph node or core needle biopsy, fine needle aspiration, and the Tiny Isothermal Nucleic Acid Amplification System (TINY) for diagnostic testing
What this could lead to
If successful, this could lead to faster, more accurate diagnosis of lymphoma and Castleman disease in people with HIV, potentially saving lives through earlier treatment.
What could go wrong
The trial is early and the new diagnostic methods may not be accurate enough to replace standard pathology. Biopsy procedures carry risks like bleeding or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

HIV infectious disease Hodgkins lymphoma Lymphadenopathy lymphatic system disorder multicentric Castleman disease non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV Hodgkin lymphoma Kaposi sarcoma herpesvirus -associated multicentric castleman disease Lymphadenopathy Non-Hodgkin lymphoma Tiny isothermal nucleic acid amplification system

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Lighthouse Trust HIV Centers of Excellence

    RECRUITING

    Lilongwe, Malawi

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