<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03252912</url>
  </required_header>
  <id_info>
    <org_study_id>ICM-URC 2015/71</org_study_id>
    <nct_id>NCT03252912</nct_id>
  </id_info>
  <brief_title>Study in Leptomeningeal Metastases of Breast Cancer</brief_title>
  <acronym>LCS Bio Sein</acronym>
  <official_title>Cerebrospinal Fluid Biomarkers Value: Exploratory and Prospective Study in Leptomeningeal Metastases of Breast Cancer (LCS Bio Sein)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut du Cancer de Montpellier - Val d'Aurelle</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut du Cancer de Montpellier - Val d'Aurelle</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Breast cancer (BC) is the most frequent cause of leptomeningeal metastases (LM) .As for brain&#xD;
      parenchymal metastases, the incidence of LM seems to be increasing, due to the growing&#xD;
      incidence of metastatic BC, the improvement of survival and the poor diffusion of therapeutic&#xD;
      agents into the central nervous system (CNS). Several prognostic factors have been&#xD;
      identified, including the age at diagnosis, the functional and neurological status, the delay&#xD;
      between the diagnosis of cancer and that of LM. The survival of patients is poor, less than 6&#xD;
      months in most published series. Several neuronal biomarkers could also be good candidates,&#xD;
      such as the neurogranin CSF and/or serum levels or the CNS neurofilaments (NF), that seem to&#xD;
      be a good reflect of axonal injury and neuronal loss. CNS NF have been investigated in&#xD;
      several neurological diseases including Alzheimer's disease, Parkinson's disease, amyotrophic&#xD;
      lateral sclerosis and multiple sclerosis, but not yet in CNS metastases. Indeed, the creation&#xD;
      of a clinico-biological collection seems to be of high value in order to investigate future&#xD;
      biomarkers of interest&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breast cancer (BC) is the most frequent cause of leptomeningeal metastases (LM). As for brain&#xD;
      parenchymal metastases, the incidence of LM seems to be increasing, due to the growing&#xD;
      incidence of metastatic BC, the improvement of survival and the poor diffusion of therapeutic&#xD;
      agents into the central nervous system (CNS). Several prognostic factors have been&#xD;
      identified, including the age at diagnosis, the functional and neurological status, the delay&#xD;
      between the diagnosis of cancer and that of LM. Other CSF biomarkers have been evaluated for&#xD;
      the diagnosis of leptomeningeal metastases. Finally, the CellSearch® technique allows for the&#xD;
      characterisation of proteins expressed by CSF tumors cells (E.G., HER2) and will make&#xD;
      possible a better understanding of the physiopathology of tumor dissemination to the CS.&#xD;
&#xD;
      Other neuronal biomarkers could be interesting for the diagnosis of LM in BC patients. Among&#xD;
      them, the protein Tau (total-Tau or T-Tau) is involved in several neurological diseases.&#xD;
      However, to date, no study has evaluated CSF or serum T-Tau in LM from solid tumors.&#xD;
&#xD;
      Several neuronal biomarkers could also be good candidates, such as the neurogranin CSF and/or&#xD;
      serum levels or the CNS neurofilaments (NF), that seem to be a good reflect of axonal injury&#xD;
      and neuronal loss.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 6, 2017</start_date>
  <completion_date type="Actual">September 15, 2020</completion_date>
  <primary_completion_date type="Actual">February 3, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity of the CellSearch® technique on CSF samples in comparison with the conventional cytology on one to three CSF sample</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>analysis of result with the 2 technical procedure</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Biological samples</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>blood samples</intervention_name>
    <description>Two EDTA tubes (5 mL) and two dried tubes (5mL) will be will be taken the same day as the first lumbar .</description>
    <arm_group_label>Biological samples</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patient ≥ 18 years-old, no age limit;&#xD;
&#xD;
          2. Histologically confirmed diagnosis of BC;&#xD;
&#xD;
          3. Hormone receptors and HER2 statuses of the primary tumor available;&#xD;
&#xD;
          4. Suspected LM based on clinical symptoms or signs, or radiological abnormalities;&#xD;
&#xD;
          5. Indication of diagnosis lumbar puncture decided by the oncologist in charge of the&#xD;
             patient;&#xD;
&#xD;
          6. Patients must be affiliated to a Social Security System;&#xD;
&#xD;
          7. Patient information and written informed consent form signed prior to any study&#xD;
             specific procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of other cancer(s) than the BC (except completely resected non-melanoma skin&#xD;
             cancer or successfully treated in situ carcinoma).&#xD;
&#xD;
          2. Hormone receptors and/or HER2 statuses of the primary tumor not available;&#xD;
&#xD;
          3. Patients with a medical contra-indication to the realization of a lumbar puncture;&#xD;
&#xD;
          4. Patients with psychological, family, sociological or geographical condition&#xD;
             potentially hampering compliance with the study protocol and follow-up schedule;&#xD;
&#xD;
          5. Patients who are pregnant or breast-feeding.&#xD;
&#xD;
          6. Legal incapacity or limited legal capacity.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>marc ychou</last_name>
    <role>Study Director</role>
    <affiliation>institut régional du Cancer de Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut régional du Cancer de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>October 16, 2020</last_update_submitted>
  <last_update_submitted_qc>October 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03252912
org study id: ICM-URC 2015/71
nct id: NCT03252912
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
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
description: analysis of result with the 2 technical procedure
arm group label: Biological samples
arm group type: Experimental
description: 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.
intervention type: Biological
intervention name: blood samples
description: Two EDTA tubes (5 mL) and two dried tubes (5mL) will be will be taken the same day as the first lumbar .
arm group label: Biological samples
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: marc ychou
role: Study Director
affiliation: institut régional du Cancer de Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms