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Spinal fluid clues could help detect breast cancer spread to the brain

NCT ID NCT03252912

Knowledge-focused Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at spinal fluid from 51 breast cancer patients whose cancer may have spread to the lining of the brain and spinal cord (leptomeningeal metastases). Researchers compared a new blood test technique (CellSearch) with standard spinal fluid analysis to see which better detects cancer cells. The goal is to find better ways to diagnose this serious complication early.

What this could mean

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

What this could lead to
If successful, this research could lead to better diagnostic tools for detecting breast cancer spread to the brain and spinal cord lining.
What could go wrong
This is an early exploratory study with only 51 participants, so findings may not apply to all patients. The biomarkers tested may not prove reliable enough for routine use.

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

51 people

The number who actually took part.

Started

Jan 2017

Finished

Sep 2020

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 years and older

Sex

Female participants only

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: 1. Male or female patient ≥ 18 years-old, no age limit; 2. Histologically confirmed diagnosis of BC; 3. Hormone receptors and HER2 statuses of the primary tumor available; 4. Suspected LM based on clinical symptoms or signs, or radiological abnormalities; 5. Indication of diagnosis lumbar puncture decided by the oncologist in charge of the patient; 6. Patients must be affiliated to a Social Security System; 7. Patient information and written informed consent form signed prior to any study specific procedures. Exclusion Criteria: 1. History of other cancer(s) than the BC (except completely resected non-melanoma skin cancer or successfully treated in situ carcinoma). 2. Hormone receptors and/or HER2 statuses of the primary tumor not available; 3. Patients with a medical contra-indication to the realization of a lumbar puncture; 4. Patients with psychological, family, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; 5. Patients who are pregnant or breast-feeding. 6. Legal incapacity or limited legal capacity.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm neoplastic meningitis

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • Institut régional du Cancer de Montpellier

    Montpellier, 34298, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.