Breast CancerExo-LCRNCT05286684
Feasibility of Exosome Analysis in Cerebrospinal Fluid During the Diagnostic Workup of Metastatic Meningitis
A study testing Consultation, Cerebral and medullary MRI, lumbar puncture, CSF sampling and biological test in people with Breast Cancer, run by Centre Oscar Lambret at 1 site in France.
Trial summary
The investigators are interested in one of the most frequent tumor types causing leptomeningeal metastasis in order to investigate whether a profile can be established by a high-throughput clinical proteomic approach. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Consultation, Cerebral and medullary MRI, lumbar puncture, CSF sampling and biological test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2023to 15 Nov 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 leptomeningeal involvement;
- Age ≥ 18 ans ;
- WHO performance status ≤ 2 ;
- Affiliation to the National Social Security System ;
- With informed and signed consent
Who cannot join
- History of another cancer than the one for which the patient is referred;
- Contraindication to lumbar puncture or cerebrospinal MRI
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Exosome Analysis in Cerebrospinal Fluid During the Diagnostic Workup of Metastatic Meningitis From Breast Cancer
The investigators are interested in one of the most frequent tumor types causing leptomeningeal metastasis in order to investigate whether a profile can be established by a high-throughput clinical proteomic approach. All the data acquired will allow a tailored and promising approach to improve the knowledge of metastatic tumor meningitis.
Read the detailed description
The primary objective is to describe on an exploratory basis the association between the type of proteomic profile from cerebrospinal fluid (CSF) microvesicles (from unsupervised bioinformatics analysis) and CSF cytology analysis (positive, negative, equivocal) in breast cancer patients with suspected leptomeningeal metastases, on initial CSF samples (hereafter referred to as initial proteomic profile and initial cytology).
- Conditions
- Breast Cancer
- Being tested
- Consultation, Cerebral and medullary MRI, lumbar puncture, CSF sampling, biological test
- Keywords
- leptomeningeal metastases, proteomic profile, cerebrospinal fluid, cytology analysis
- 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.
ConsultationProcedure or surgery
History of the disease, anatomopathological and molecular biological data concerning the initial tumor; Collection of treatments received and/or in progress by the patient for her meningeal tumor (chemotherapy, targeted therapy, radiotherapy, surgery, corticosteroids, antiepileptics); Evaluation of the general condition and neurological status.
Cerebral and medullary MRI, lumbar puncture, CSF samplingProcedure or surgery
diagnosis of leptomeningeal involvement
biological testBiological
5 ml of additional CSF after diagnostic lumbar puncture for proteomic analysis, 50-100 µl of breast aspiration fluid (NAF) for patients with an existing breast tumor, for proteomic analysis 10 ml of blood for proteomic analysis
| Study group | Role | What they receive |
|---|---|---|
| Study process | Experimental | Consultation, Cerebral and medullary MRI, lumbar puncture, CSF sampling, blood sample, collection of breast fluid Receives: Procedure: Consultation; Procedure: Cerebral and medullary MRI, lumbar puncture, CSF sampling; Biological: biological test |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF protein composition
The CSF proteomic profile will be obtained by an unsupervised bioinformatics analysis of the CSF collected during the initial diagnostic workup for all patients and in case of renewal of the initial lumbar puncture if the 1st one was not exploitable for the CSF cytological analysis.
The bioinformatics analysis will allow to obtain the protein composition and to establish proteomic profile.
Measured: 36 months
cytological analysis of the CSF
The cytological analysis of the CSF will allow to obtain 3 possible results: Positive / Negative / Equivocal at the time of the initial diagnostic workup for all patients and in case of renewal of the initial LP if the 1st one was not exploitable for the cytological analysis of the CSF, for all patients.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start4 Jan 2023
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Cheymol, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286684
- Sponsor's protocol ID
- Exo-LCR-1807
- Other IDs
- 2021-A01558-33
- Acronym
- Exo-LCR
- Status last verified
- Mar 2026
- First submitted
- 31 Jan 2022
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Exosome Analysis in Cerebrospinal Fluid During the Diagnostic Workup of Metastatic Meningitis From Breast Cancer
- ClinicalTrials.gov ID
- NCT05286684
- Acronym / sponsor ID
- Exo-LCR / Exo-LCR-1807
- Conditions
- Breast Cancer
- Keywords
- leptomeningeal metastases, proteomic profile, cerebrospinal fluid, cytology analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 18 Mar 2022 (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.
The investigators are interested in one of the most frequent tumor types causing leptomeningeal metastasis in order to investigate whether a profile can be established by a high-throughput clinical proteomic approach. All the data acquired will allow a tailored and promising approach to improve the knowledge of metastatic tumor meningitis.
Detailed description
The primary objective is to describe on an exploratory basis the association between the type of proteomic profile from cerebrospinal fluid (CSF) microvesicles (from unsupervised bioinformatics analysis) and CSF cytology analysis (positive, negative, equivocal) in breast cancer patients with suspected leptomeningeal metastases, on initial CSF samples (hereafter referred to as initial proteomic profile and initial cytology).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study process | Experimental | Procedure: Consultation, Procedure: Cerebral and medullary MRI, lumbar puncture, CSF sampling, Biological: biological testConsultation, Cerebral and medullary MRI, lumbar puncture, CSF sampling, blood sample, collection of breast fluid |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with histologically proven breast cancer;
- Patient with suspected metastatic leptomeningeal involvement;
- Age ≥ 18 ans ;
- WHO performance status ≤ 2 ;
- Affiliation to the National Social Security System ;
Key exclusion criteria (3 listed)
- History of another cancer than the one for which the patient is referred;
- Contraindication to lumbar puncture or cerebrospinal MRI
- Pregnant or breastfeeding woman
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 |
|---|---|---|
| ConsultationHistory of the disease, anatomopathological and molecular biological data concerning the initial tumor; Collection of treatments received and/or in progress by the patient for her meningeal tumor (chemotherapy, targeted therapy, radiotherapy, surgery, corticosteroids, antiepileptics); Evaluation of the general condition and neurological status. | Procedure or surgery | Study process |
| Cerebral and medullary MRI, lumbar puncture, CSF samplingdiagnosis of leptomeningeal involvement | Procedure or surgery | Study process |
| biological test5 ml of additional CSF after diagnostic lumbar puncture for proteomic analysis, 50-100 µl of breast aspiration fluid (NAF) for patients with an existing breast tumor, for proteomic analysis 10 ml of blood for proteomic analysis | Biological | Study process |
Primary outcome
CSF protein composition
Time frame: 36 months
The CSF proteomic profile will be obtained by an unsupervised bioinformatics analysis of the CSF collected during the initial diagnostic workup for all patients and in case of renewal of the initial lumbar puncture if the 1st one was not exploitable for the CSF cytological analysis. The bioinformatics analysis will allow to obtain the protein composition and to establish proteomic profile.
cytological analysis of the CSF
Time frame: 36 months
The cytological analysis of the CSF will allow to obtain 3 possible results: Positive / Negative / Equivocal at the time of the initial diagnostic workup for all patients and in case of renewal of the initial LP if the 1st one was not exploitable for the cytological analysis of the CSF, for all patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Claire Cheymol, MD principal investigator
Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consultation, Cerebral and medullary MRI, lumbar puncture, CSF sampling and biological test in people with Breast Cancer, run by Centre Oscar Lambret at 1 site 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 6 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: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CSF protein composition (time frame: 36 months). 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 18 Mar 2026.