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Analyses of Exosomes in the Cerebrospinal Fluid for Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.

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ClinicalTrials.gov Identifier: NCT03974204
Recruitment Status : Not yet recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Leptomeningeal Metastasis 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 Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Benefit of Analyzing Exosomes in the Cerebrospinal Fluid During the Medical Care of Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Cerebrospinal fluid and Blood sample collection

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.
Procedure: Cerebrospinal fluid and blood sample collection at the initial diagnostic assessment
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.

Procedure: Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "Lack of evidence" according to EANO-ESMO classification

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.

Procedure: Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "confirmed", "probable" or "possible", leading to leptomeningeal metastase specific treatment

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.




Primary Outcome Measures :
  1. 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.

  2. Cytology of cerebrospinal fluid at diagnosis [ Time Frame: Up to 1 week ]
    Results of cytological analysis of cerebrospinal fluid will be "Positive", "negative", "equivocal".


Secondary Outcome Measures :
  1. Proteomic profiles issued from cerebrospinal fluid [ Time Frame: Up to 3 months ]

    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".

  2. Histological subtype [ Time Frame: Before registration in study ]
    Histological subtype will be subdivised as invasive ductal breast carcinoma, invasive lobular breast carcinoma, other brest carcinoma.

  3. Hormonal receptors status [ Time Frame: Before registration in study ]

    Hormonal receptors status will be subdivised as:

    • Positive hormonal receptors / Positive HER2
    • Positive hormonal receptors / Negative HER2
    • Negative hormonal receptors / Positive HER2
    • Triple negative

  4. Likehood of leptomeningeal metastasis according to the EANO-ESMO classification. [ Time Frame: Up to 3 months after the intial diagnosis ]

    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.

  5. Overall survival [ Time Frame: Time from date of registration to date of death regardless of the cause, assessed up to 1 year ]
    Overall survival is defined as time from date of registration to date of death regardless of the cause.

  6. Proteomic profiles issued from blood [ Time Frame: Up to 3 months after the intial diagnosis ]
    Proteomic profile will be obtained by bioinformatic analysis of blood.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • History of cancer other than the one being treated
  • Contraindication to carrying out the lumbar puncture or cerebrospinal MRI
  • Pregnant or breastfeeding patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974204


Contacts
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Contact: Julien THERY +33 (0)3 20 29 59 18 promotion@o-lambret.fr

Locations
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France
Centre Oscar Lambret Not yet recruiting
Lille, Hauts-de- France, France, 59020
Contact: Emilie LE RHUN, MD    +33 (0)3 20 29 59 35    e-lerhun@o-lambret.fr   
Principal Investigator: Emilie LE RHUN, MD         
Sub-Investigator: Laurence VANLEMMENS, MD         
Sub-Investigator: Audrey MAILLIEZ, MD         
Centre Hospitalier Régional Universitaire de Lille Not yet recruiting
Lille, Hauts-de-France, France, 59000
Contact: Emilie LE RHUN, MD    +33 (0)3 20 44 59 62    emilie.lerhun@chru-lille.fr   
Principal Investigator: Emilie LE RHUN, MD         
Sub-Investigator: Christophe DESAUW, MD         
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
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Principal Investigator: Emilie LE RHUN, MD Centre Oscar Lambret

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Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT03974204     History of Changes
Other Study ID Numbers: Exo-LCR-1807
2018-A02358-47 ( Other Identifier: N°ID RCB )
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Oscar Lambret:
Cerebrospinal fluid
Proteomic profile

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Meningeal Carcinomatosis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Nervous System Diseases