Breast CancerLCS Bio SeinNCT03252912
Study in Leptomeningeal Metastases of Breast Cancer
A study testing blood samples in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
Breast cancer (BC) is the most frequent cause of leptomeningeal metastases (LM) .As for brain parenchymal metastases, the incidence of LM seems to be increasing, due to the growing incidence of metastatic BC, the improvement of survival and the poor diffusion of therapeutic agents into the central nervous system… 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?
- blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2017to 15 Sep 2020
- 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
- Male or female patient ≥ 18 years-old, no age limit;
- Histologically confirmed diagnosis of BC;
- Hormone receptors and HER2 statuses of the primary tumor available;
- Suspected LM based on clinical symptoms or signs, or radiological abnormalities;
- Indication of diagnosis lumbar puncture decided by the oncologist in charge of the patient;
- Patients must be affiliated to a Social Security System;
- Patient information and written informed consent form signed prior to any study specific procedures.
Who cannot join
- History of other cancer(s) than the BC (except completely resected non-melanoma skin cancer or successfully treated in situ carcinoma).
- Hormone receptors and/or HER2 statuses of the primary tumor not available;
- Patients with a medical contra-indication to the realization of a lumbar puncture;
- Patients with psychological, family, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
- Patients who are pregnant or breast-feeding.
- Legal incapacity or limited legal capacity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebrospinal Fluid Biomarkers Value: Exploratory and Prospective Study in Leptomeningeal Metastases of Breast Cancer (LCS Bio Sein)
Breast cancer (BC) is the most frequent cause of leptomeningeal metastases (LM) .As for brain parenchymal metastases, the incidence of LM seems to be increasing, due to the growing incidence of metastatic BC, the improvement of survival and the poor diffusion of therapeutic agents into the central nervous system (CNS). Several prognostic factors have been identified, including the age at diagnosis, the functional and neurological status, the delay between the diagnosis of cancer and that of LM. The survival of patients is poor, less than 6 months in most published series. Several neuronal biomarkers could also be good candidates, such as the neurogranin CSF and/or serum levels or the CNS neurofilaments (NF), that seem to be a good reflect of axonal injury and neuronal loss. CNS NF have been investigated in several neurological diseases including Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis and multiple sclerosis, but not yet in CNS metastases. Indeed, the creation of a clinico-biological collection seems to be of high value in order to investigate future biomarkers of interest
Read the detailed description
Breast cancer (BC) is the most frequent cause of leptomeningeal metastases (LM). As for brain parenchymal metastases, the incidence of LM seems to be increasing, due to the growing incidence of metastatic BC, the improvement of survival and the poor diffusion of therapeutic agents into the central nervous system (CNS). Several prognostic factors have been identified, including the age at diagnosis, the functional and neurological status, the delay between the diagnosis of cancer and that of LM. Other CSF biomarkers have been evaluated for the diagnosis of leptomeningeal metastases. Finally, the CellSearch® technique allows for the characterisation of proteins expressed by CSF tumors cells (E.G., HER2) and will make possible a better understanding of the physiopathology of tumor dissemination to the CS.
Other neuronal biomarkers could be interesting for the diagnosis of LM in BC patients. Among them, the protein Tau (total-Tau or T-Tau) is involved in several neurological diseases. However, to date, no study has evaluated CSF or serum T-Tau in LM from solid tumors.
Several neuronal biomarkers could also be good candidates, such as the neurogranin CSF and/or serum levels or the CNS neurofilaments (NF), that seem to be a good reflect of axonal injury and neuronal loss.
- Conditions
- Breast Cancer
- Being tested
- blood samples
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesBiological
Two EDTA tubes (5 mL) and two dried tubes (5mL) will be will be taken the same day as the first lumbar .
| Study group | Role | What they receive |
|---|---|---|
| Biological samples | Experimental | The CSF samples will be taken at the occasion of the first lumbar puncture performed for clinical purposes (suspected LM). If necessary for the routine diagnosis, a second and a third lumbar puncture will be performed according to the gold standard Two EDTA tubes (5 mL) and two dried tubes (5mL) will be will be taken the same day as the first lumbar puncture and transferred at ambient temperature to the Biological Resource Center of the ICM (Jean-Pierre Bleuse, Biobank number BB-0033-00059) to be processed within 1 hour Blood samples will be centrifuged at 3,000 g for 10 minutes at ambient temperature and will be aliquoted in 4 plasma and 4 serum aliquots and then stored at -80°C. Aliquots must be anonymized. Receives: Biological: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the CellSearch® technique on CSF samples in comparison with the conventional cytology on one to three CSF sample
analysis of result with the 2 technical procedure
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start6 Jan 2017
- Primary completion3 Feb 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- marc ychou, Study director, institut régional du Cancer de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252912
- Sponsor's protocol ID
- ICM-URC 2015/71
- Acronym
- LCS Bio Sein
- Status last verified
- Mar 2026
- First submitted
- 10 Aug 2017
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Darlix A, Cayrefourcq L, Pouderoux S, Menjot de Champfleur N, Bievelez A, Jacot W, Leaha C, Thezenas S, Alix-Panabieres C. Detection of Circulating Tumor Cells in Cerebrospinal Fluid of Patients with Suspected Breast Cancer Leptomeningeal Metastases: A Prospective Study. Clin Chem. 2022 Oct 6;68(10):1311-1322. doi: 10.1093/clinchem/hvac127.
PubMed 35953885Delaby C, Al Herk A, Hirtz C, Jacot W, Laigre M, Pouderoux S, Pradeilles N, Lehmann S, Darlix A. Hepcidin as an emerging predictor biomarker of leptomeningeal metastases in patients with metastatic breast cancer. BMC Cancer. 2025 Nov 21;25(1):1801. doi: 10.1186/s12885-025-15124-6.
PubMed 41272605
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrospinal Fluid Biomarkers Value: Exploratory and Prospective Study in Leptomeningeal Metastases of Breast Cancer (LCS Bio Sein)
- ClinicalTrials.gov ID
- NCT03252912
- Acronym / sponsor ID
- LCS Bio Sein / ICM-URC 2015/71
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 6 Jan 2017 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 17 Aug 2017 (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.
Breast cancer (BC) is the most frequent cause of leptomeningeal metastases (LM) .As for brain parenchymal metastases, the incidence of LM seems to be increasing, due to the growing incidence of metastatic BC, the improvement of survival and the poor diffusion of therapeutic agents into the central nervous system (CNS). Several prognostic factors have been identified, including the age at diagnosis, the functional and neurological status, the delay between the diagnosis of cancer and that of LM. The survival of patients is poor, less than 6 months in most published series. Several neuronal biomarkers could also be good candidates, such as the neurogranin CSF and/or serum levels or the CNS neurofilaments (NF), that seem to be a good reflect of axonal injury and neuronal loss. CNS NF have been investigated in several neurological diseases including Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis and multiple sclerosis, but not yet in CNS metastases. Indeed, the creation of a clinico-biological collection seems to be of high value in order to investigate future biomarkers of interest
Detailed description
Breast cancer (BC) is the most frequent cause of leptomeningeal metastases (LM). As for brain parenchymal metastases, the incidence of LM seems to be increasing, due to the growing incidence of metastatic BC, the improvement of survival and the poor diffusion of therapeutic agents into the central nervous system (CNS). Several prognostic factors have been identified, including the age at diagnosis, the functional and neurological status, the delay between the diagnosis of cancer and that of LM. Other CSF biomarkers have been evaluated for the diagnosis of leptomeningeal metastases. Finally, the CellSearch® technique allows for the characterisation of proteins expressed by CSF tumors cells (E.G., HER2) and will make possible a better understanding of the physiopathology of tumor dissemination to the CS.
Other neuronal biomarkers could be interesting for the diagnosis of LM in BC patients. Among them, the protein Tau (total-Tau or T-Tau) is involved in several neurological diseases. However, to date, no study has evaluated CSF or serum T-Tau in LM from solid tumors.
Several neuronal biomarkers could also be good candidates, such as the neurogranin CSF and/or serum levels or the CNS neurofilaments (NF), that seem to be a good reflect of axonal injury and neuronal loss.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological samples | Experimental | Biological: blood samplesThe CSF samples will be taken at the occasion of the first lumbar puncture performed for clinical purposes (suspected LM). If necessary for the routine diagnosis, a second and a third lumbar puncture will be performed according to the gold standard Two EDTA tubes (5 mL) and two dried tubes (5mL) will be will be taken the same day as the first lumbar puncture and transferred at ambient temperature to the Biological Resource Center of the ICM (Jean-Pierre Bleuse, Biobank number BB-0033-00059) to be processed within 1 hour Blood samples will be centrifuged at 3,000 g for 10 minutes at ambient temperature and will be aliquoted in 4 plasma and 4 serum aliquots and then stored at -80°C. Aliquots must be anonymized. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patient ≥ 18 years-old, no age limit;
- Histologically confirmed diagnosis of BC;
- Hormone receptors and HER2 statuses of the primary tumor available;
- Suspected LM based on clinical symptoms or signs, or radiological abnormalities;
- Indication of diagnosis lumbar puncture decided by the oncologist in charge of the patient;
Key exclusion criteria (6 listed)
- History of other cancer(s) than the BC (except completely resected non-melanoma skin cancer or successfully treated in situ carcinoma).
- Hormone receptors and/or HER2 statuses of the primary tumor not available;
- Patients with a medical contra-indication to the realization of a lumbar puncture;
- Patients with psychological, family, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
- Patients who are pregnant or breast-feeding.
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 |
|---|---|---|
| blood samplesTwo EDTA tubes (5 mL) and two dried tubes (5mL) will be will be taken the same day as the first lumbar . | Biological | Biological samples |
Primary outcome
Sensitivity of the CellSearch® technique on CSF samples in comparison with the conventional cytology on one to three CSF sample
Time frame: through study completion, an average of 2 years
analysis of result with the 2 technical procedure
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 12 Mar 2026.
- Background: PubMed 35953885Darlix A, Cayrefourcq L, Pouderoux S, Menjot de Champfleur N, Bievelez A, Jacot W, Leaha C, Thezenas S, Alix-Panabieres C. Detection of Circulating Tumor Cells in Cerebrospinal Fluid of Patients with Suspected Breast Cancer Leptomeningeal Metastases: A Prospective Study. Clin Chem. 2022 Oct 6;68(10):1311-1322. doi: 10.1093/clinchem/hvac127.
- Results publication: PubMed 41272605Delaby C, Al Herk A, Hirtz C, Jacot W, Laigre M, Pouderoux S, Pradeilles N, Lehmann S, Darlix A. Hepcidin as an emerging predictor biomarker of leptomeningeal metastases in patients with metastatic breast cancer. BMC Cancer. 2025 Nov 21;25(1):1801. doi: 10.1186/s12885-025-15124-6.
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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.
marc ychou study director
institut régional du Cancer de Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle 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 7 inclusion and 6 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 12 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?
Sensitivity of the CellSearch® technique on CSF samples in comparison with the conventional cytology on one to three CSF sample (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03252912, which also lists 2 linked publications.
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 12 Mar 2026.