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Spinal fluid DNA test could personalize brain cancer therapy

NCT ID NCT07689721

Diagnosis Sponsor: Alireza Mansouri Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This study explores whether analyzing tumor DNA in cerebrospinal fluid can help doctors make better treatment decisions for people with malignant brain tumors or brain metastases from lung or breast cancer. Participants undergo a standard spinal tap or fluid collection, and the fluid is tested with a special DNA assay alongside usual methods. The goal is to see if this test improves how well the disease is controlled in the central nervous system over six months, while also monitoring safety. The results could lead to more personalized and timely treatments for these serious conditions.

What this could mean

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

Active substance
Belay Summit CSF ctDNA assay (diagnostic test)
What this could lead to
If successful, this approach could help doctors tailor treatments more precisely for brain cancer patients, potentially improving survival and reducing unnecessary therapies.
What could go wrong
This is an early-stage, single-center study with a small sample size. The test may not reliably predict outcomes, and treatment decisions are not standardized, limiting generalizability.

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 77 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 2032

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

18 to 120 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: * Age ≥ 18 years. * Diagnosis of histologically or cytologically confirmed HER2+ breast cancer, or triple negative breast cancer, or Stage IV non-small cell lung cancer, or recurrent high-grade glioma). * Undergoing clinically indicated cerebrospinal fluid (CSF) collection as part of routine clinical care: CSF may be obtained via lumbar puncture or existing CSF access device. Decision for CSF collection must be made independently by the treating clinical team and not solely for research purposes. * Detectable CSF ctDNA and/or positive CSF cytology, with consideration for CNS-directed management by the treating neuro-oncology team. * Ability to provide informed consent, or availability of a legally authorized representative (LAR). Exclusion Criteria: * Age \<18 years. * Inability to provide informed consent and no legally authorized representative (LAR) available. * Not undergoing clinically indicated CSF collection as part of standard clinical care. * Absence of detectable CSF ctDNA and absence of positive CSF cytology. * Not being considered for CNS-directed management by the treating neuro-oncology team. * Clinical contraindications to CSF collection, including but not limited to: Significant intracranial mass effect; (e.g., midline shift \>5 mm or effacement of basal cisterns); Obstructive hydrocephalus or posterior fossa mass effect; Coagulopathy or bleeding risk precluding lumbar puncture or CSF access; Inability to safely obtain CSF access.

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Conditions

The condition(s) this trial relates to.

brain cancer breast cancer breast neoplasm glioblastoma malignant glioma Meningeal Neoplasms metastatic malignant neoplasm in the brain neoplastic meningitis non-small cell lung carcinoma

As listed by the trial registrant

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

Brain metastases Breast cancer Glioblastoma Leptomeningeal disease Non small cell lung cancer

How to take part

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  1. 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 ↗

  2. 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.

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