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Spinal fluid DNA test could replace brain biopsies for a rare lymphoma

NCT ID NCT07851363

Diagnosis Sponsor: Xiaohui Ren Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 01, 2026 · Last updated Oct 02, 2026 · Updated 1 time

Summary

Primary central nervous system lymphoma grows fast and often leaves patients critically ill, so doctors need a quick, safe way to diagnose it and track how treatment is working. Brain biopsies are invasive and can be risky or delayed. This study collects spinal fluid from 300 adults with confirmed disease and sequences circulating tumor DNA across more than 100 genes, comparing it with tissue samples and building AI models to spot the disease early and predict treatment response.

What this could mean

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

Active substance
cerebrospinal fluid circulating tumor DNA liquid biopsy, alongside high-dose methotrexate chemotherapy and a BTK inhibitor
What this could lead to
If it works, doctors could diagnose and monitor primary central nervous system lymphoma with a spinal fluid test instead of repeated brain biopsies, catching relapse earlier and adjusting treatment sooner.
What could go wrong
The approach is still being validated in a large group, and ctDNA may be too scarce in spinal fluid to detect in some patients. A negative test might miss disease that a biopsy would catch, and the AI models need broad data before they can be trusted.

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.

Participants

About 300 people

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

Started

Jan 2026

Expected to finish

Dec 2029

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.

Who is studied

patients who have radiologically suspected PCNSL

Ages

18 to 75 years

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: * Patients with pathologically confirmed primary central nervous system lymphoma; * Lesions confined to the central nervous system (cerebral parenchyma, meninges, spinal cord or intraocular), with no evidence of systemic lymphoma; * Aged ≥ 18 years and ≤ 75 years, no restriction on gender; * Expected survival of more than 3 months; * The subjects voluntarily join this study, understand the trial procedures and contents, sign the informed consent form, have good compliance and cooperate with follow-up. Exclusion Criteria: * Other types of central nervous system tumors; * Without pathological confirmation basis; * Patients complicated with other malignant tumors; * Other conditions that are considered by the investigators to be unsuitable for participating in this trial.

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Conditions

The condition(s) this trial relates to.

primary central nervous system lymphoma

As listed by the trial registrant

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

Primary central nervous system lymphoma

How to take part

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  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

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Contacts and locations

Locations

  • Deparment of neurosurgery, Beijing tiantan hospital

    RECRUITING

    Beijing, Beijing Municipality, 100070, China

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