Breast CancerNCT03974204
Analyses of Exosomes in the Cerebrospinal Fluid for Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.
A study testing Cerebrospinal fluid and blood sample collection at the initial diagnostic assessment, Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "Lack of evidence" according to EANO-ESMO classification and Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "confirmed", "probable" or "possible", leading to leptomeningeal metastase specific treatment in people with Breast Cancer and Leptomeningeal Metastasis, run by Centre Oscar Lambret at 2 sites in France.
Trial summary
This is a multicenter, interventional, prospective study among breast cancer patients with a suspicion of metastatic meningitis. The current study aims to assess the use of proteomic profile issued from cerebrospinal fluid microvesicles for diagnosis of leptomeningeal metastases. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Leptomeningeal Metastasis
- What is being tested?
- Cerebrospinal fluid and blood sample collection at the initial diagnostic assessment, Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "Lack of evidence" according to EANO-ESMO classification and Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "confirmed", "probable" or "possible", leading to leptomeningeal metastase specific treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2019to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with histologically proven breast cancer
- Patient with suspected metastatic leptomeningitis
- Age ≥ 18 years
- Patient covered by the French social security regime
- Signed written informed consent
Who cannot join
- History of cancer other than the one being treated
- Contraindication to carrying out the lumbar puncture or cerebrospinal MRI
- Pregnant or breastfeeding patient
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Régional Universitaire de Lille
Lille, Hauts-de-France, 59000
Centre Oscar Lambret
Lille, Hauts-de-France, 59020
About this study
Official title: Benefit of Analyzing Exosomes in the Cerebrospinal Fluid During the Medical Care of Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.
This is a multicenter, interventional, prospective study among breast cancer patients with a suspicion of metastatic meningitis. The current study aims to assess the use of proteomic profile issued from cerebrospinal fluid microvesicles for diagnosis of leptomeningeal metastases.
Read the detailed description
The aim of this study is to describe the association between the initial proteomic profile issued from cerebrospinal fluid microvesicles and the initial cytological analysis of the cerebrospinal fluid in breast cancer patients with a suspicion of metastatic meningitis.
Other objectives of the study include:
- Describing the association between the initial proteomic profile and:
- the histological types and hormonal receptors status of the breast cancer,
- the likelihood of leptomeningeal metastasis according to the EANO-ESMO classification (Lack of evidence / possible / probable / confirmed) ,
- the likelihood of leptomeningeal metastasis according to the EANO-ESMO classification, combined with histological type and hormonal receptors status.
- Evaluate the prognostic value of the proteomic profiling for overall survival, according to the EANO-ESMO classification and other known prognosis factors, in patients classified "possible", "probable" or "confirmed" leading to leptomeningeal metastases specific treatment,
- Evaluate the impact of the evolution of the proteomic profile a month after the start of this treatment on the overall survival, in patients with leptomeningeal metastases specific treatment,
- Evaluate the association between the proteomic profile and the EANO-ESMO classification at least 3 months after the initial EANO-ESMO classification,
- Evaluate the evolution of the proteomic profile 3 months after the initial EANO-ESMO classification, in patients initially classified "lack of evidence", broadly and according to the evolution of cytology, the administered treatments and to the EANO-ESMO response if applicable,
- Compare the proteomic profiles issued from cerebrospinal fluid and blood
- Conditions
- Breast Cancer, Leptomeningeal Metastasis
- Being tested
- Cerebrospinal fluid and blood sample collection at the initial diagnostic assessment, Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "Lack of evidence" according to EANO-ESMO classification, Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "confirmed", "probable" or "possible", leading to leptomeningeal metastase specific treatment
- Keywords
- Cerebrospinal fluid, Proteomic profile
- Medical subject headings
- Breast Neoplasms, Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebrospinal fluid and blood sample collection at the initial diagnostic assessmentProcedure or surgery
At the initial diagnostic assessment, 3mL of cerebrospinal fluid and 10 ml of blood sample will be collected in order to determine the proteomic profile. Cerebrospinal fluid will be collected during a lumbar puncture aiming to diagnose leptomeningeal metastases.
Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "Lack of evidence" according to EANO-ESMO classificationProcedure or surgery
3mL of cerebrospinal fluid and 10 ml of blood sample will be collected:
- When suspected metastatic meningitis symptoms arise and
- at least 3 months after the initial diagnostic assessment, In order to determine the proteomic profile. Cerebrospinal fluid will be collected during a lumbar puncture aiming to diagnose leptomeningeal metastases.
Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "confirmed", "probable" or "possible", leading to leptomeningeal metastase specific treatmentProcedure or surgery
3mL of cerebrospinal fluid and 10 ml of blood sample will be collected:
- 1 month after the beginning of the specific treatment,
- 3 months after the beginning of the specific treatment. Cerebrospinal fluid will be collected during a lumbar puncture aiming to assess treatment response or at intrathecal injection of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Cerebrospinal fluid and Blood sample collection | Experimental | Collection of cerebrospinal fluid and blood samples:
* At initial diagnostic assessment;
* 1 month and 3 months after initial diagnostic assessment, for patients classified "possible", "probable" or "confirmed" according to EANO-ESMO classification, leading to specific leptomeningeal metastase treatment;
* In case of symptoms leading to leptomeningeal metastase suspicion and at least 3 months after diagnostic assessment, for patients classified "lack of evidence" according to EANO-ESMO classification. Receives: Procedure: Cerebrospinal fluid and blood sample collection at the initial diagnostic assessment; Procedure: Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "Lack of evidence" according to EANO-ESMO classification; Procedure: Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "confirmed", "probable" or "possible", leading to leptomeningeal metastase specific treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteomic profiles issued from cerebrospinal fluid at diagnosis
Proteomic profile will be obtained by bioinformatic analysis of cerebrospinal fluid.
Measured: Up to 1 week
Cytology of cerebrospinal fluid at diagnosis
Results of cytological analysis of cerebrospinal fluid will be "Positive", "negative", "equivocal".
Measured: Up to 1 week
Secondary outcomes (6)
Proteomic profiles issued from cerebrospinal fluid
Proteomic profile will be obtained by bioinformatic analysis of cerebrospinal fluid:
- 1 month and 3 month after the start of a specific treatment of the leptomeningeal metastasis, if applicable,
- 3 months after the initial diagnosis of leptomeningeal metastasis if the likehood of leptomeningeal metastasis is "lack of evidence".
Measured: Up to 3 months
Histological subtype
Histological subtype will be subdivised as invasive ductal breast carcinoma, invasive lobular breast carcinoma, other brest carcinoma.
Measured: Before registration in study
Hormonal receptors status
Hormonal receptors status will be subdivised as:
- Positive hormonal receptors / Positive HER2
- Positive hormonal receptors / Negative HER2
- Negative hormonal receptors / Positive HER2
- Triple negative
Measured: Before registration in study
Likehood of leptomeningeal metastasis according to the EANO-ESMO classification.
EANO-ESMO classification is obtained by searching clinical symptoms, cancer cells in the cerebrospinal fluid (obtained by lumbar puncture), signs in RMI. The likehood of leptomeningeal metastasis is:
- Lack of evidence,
- Possible,
- Probable,
- Confirmed.
Measured: Up to 3 months after the intial diagnosis
Overall survival
Overall survival is defined as time from date of registration to date of death regardless of the cause.
Measured: Time from date of registration to date of death regardless of the cause, assessed up to 1 year
Proteomic profiles issued from blood
Proteomic profile will be obtained by bioinformatic analysis of blood.
Measured: Up to 3 months after the intial diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study startJul 2019 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2023 (estimated)
Why it stopped: Modification of the care habits. We believe today that we are no longer able to carry out this study as initially described.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie LE RHUN, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974204
- Sponsor's protocol ID
- Exo-LCR
- Other IDs
- 2018-A02358-47
- Status last verified
- Oct 2021
- First submitted
- 31 May 2019
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Analyzing Exosomes in the Cerebrospinal Fluid During the Medical Care of Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.
- ClinicalTrials.gov ID
- NCT03974204
- Acronym / sponsor ID
- Exo-LCR
- Conditions
- Breast Cancer, Leptomeningeal Metastasis
- Keywords
- Cerebrospinal fluid, Proteomic profile
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Modification of the care habits. We believe today that we are no longer able to carry out this study as initially described.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, interventional, prospective study among breast cancer patients with a suspicion of metastatic meningitis. The current study aims to assess the use of proteomic profile issued from cerebrospinal fluid microvesicles for diagnosis of leptomeningeal metastases.
Detailed description
The aim of this study is to describe the association between the initial proteomic profile issued from cerebrospinal fluid microvesicles and the initial cytological analysis of the cerebrospinal fluid in breast cancer patients with a suspicion of metastatic meningitis.
Other objectives of the study include:
- Describing the association between the initial proteomic profile and:
- the histological types and hormonal receptors status of the breast cancer,
- the likelihood of leptomeningeal metastasis according to the EANO-ESMO classification (Lack of evidence / possible / probable / confirmed) ,
- the likelihood of leptomeningeal metastasis according to the EANO-ESMO classification, combined with histological type and hormonal receptors status.
- Evaluate the prognostic value of the proteomic profiling for overall survival, according to the EANO-ESMO classification and other known prognosis factors, in patients classified "possible", "probable" or "confirmed" leading to leptomeningeal metastases specific treatment,
- Evaluate the impact of the evolution of the proteomic profile a month after the start of this treatment on the overall survival, in patients with leptomeningeal metastases specific treatment,
- Evaluate the association between the proteomic profile and the EANO-ESMO classification at least 3 months after the initial EANO-ESMO classification,
- Evaluate the evolution of the proteomic profile 3 months after the initial EANO-ESMO classification, in patients initially classified "lack of evidence", broadly and according to the evolution of cytology, the administered treatments and to the EANO-ESMO response if applicable,
- Compare the proteomic profiles issued from cerebrospinal fluid and blood
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebrospinal fluid and Blood sample collection | Experimental | Procedure: Cerebrospinal fluid and blood sample collection at the initial diagnostic assessment, Procedure: Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "Lack of evidence" according to EANO-ESMO classification, Procedure: Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "confirmed", "probable" or "possible", leading to leptomeningeal metastase specific treatmentCollection of cerebrospinal fluid and blood samples: * At initial diagnostic assessment; * 1 month and 3 months after initial diagnostic assessment, for patients classified "possible", "probable" or "confirmed" according to EANO-ESMO classification, leading to specific leptomeningeal metastase treatment; * In case of symptoms leading to leptomeningeal metastase suspicion and at least 3 months after diagnostic assessment, for patients classified "lack of evidence" according to EANO-ESMO classification. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with histologically proven breast cancer
- Patient with suspected metastatic leptomeningitis
- Age ≥ 18 years
- Patient covered by the French social security regime
- Signed written informed consent
Key exclusion criteria (3 listed)
- History of cancer other than the one being treated
- Contraindication to carrying out the lumbar puncture or cerebrospinal MRI
- Pregnant or breastfeeding patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebrospinal fluid and blood sample collection at the initial diagnostic assessmentAt the initial diagnostic assessment, 3mL of cerebrospinal fluid and 10 ml of blood sample will be collected in order to determine the proteomic profile. Cerebrospinal fluid will be collected during a lumbar puncture aiming to diagnose leptomeningeal metastases. | Procedure or surgery | Cerebrospinal fluid and Blood sample collection |
| Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "Lack of evidence" according to EANO-ESMO classification3mL of cerebrospinal fluid and 10 ml of blood sample will be collected: * When suspected metastatic meningitis symptoms arise and * at least 3 months after the initial diagnostic assessment, In order to determine the proteomic profile. Cerebrospinal fluid will be collected during a lumbar puncture aiming to diagnose leptomeningeal metastases. | Procedure or surgery | Cerebrospinal fluid and Blood sample collection |
| Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "confirmed", "probable" or "possible", leading to leptomeningeal metastase specific treatment3mL of cerebrospinal fluid and 10 ml of blood sample will be collected: * 1 month after the beginning of the specific treatment, * 3 months after the beginning of the specific treatment. Cerebrospinal fluid will be collected during a lumbar puncture aiming to assess treatment response or at intrathecal injection of treatment. | Procedure or surgery | Cerebrospinal fluid and Blood sample collection |
Primary outcome
Proteomic profiles issued from cerebrospinal fluid at diagnosis
Time frame: Up to 1 week
Proteomic profile will be obtained by bioinformatic analysis of cerebrospinal fluid.
Cytology of cerebrospinal fluid at diagnosis
Time frame: Up to 1 week
Results of cytological analysis of cerebrospinal fluid will be "Positive", "negative", "equivocal".
6 secondary outcomes
Proteomic profiles issued from cerebrospinal fluid
Time frame: Up to 3 months
Histological subtype
Time frame: Before registration in study
Hormonal receptors status
Time frame: Before registration in study
Likehood of leptomeningeal metastasis according to the EANO-ESMO classification.
Time frame: Up to 3 months after the intial diagnosis
Overall survival
Time frame: Time from date of registration to date of death regardless of the cause, assessed up to 1 year
Proteomic profiles issued from blood
Time frame: Up to 3 months after the intial diagnosis
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie LE RHUN, MD principal investigator
Centre Oscar Lambret
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebrospinal fluid and blood sample collection at the initial diagnostic assessment, Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "Lack of evidence" according to EANO-ESMO classification and Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "confirmed", "probable" or "possible", leading to leptomeningeal metastase specific treatment in people with Breast Cancer and Leptomeningeal Metastasis, run by Centre Oscar Lambret at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteomic profiles issued from cerebrospinal fluid at diagnosis (time frame: Up to 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.