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

Sponsor

Centre Oscar Lambret (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03974204

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

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.

Anticipated Study Start Date :

Jul 1, 2019

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Proteomic profiles issued from cerebrospinal fluid at diagnosis [Up to 1 week]
Proteomic profile will be obtained by bioinformatic analysis of cerebrospinal fluid.
Cytology of cerebrospinal fluid at diagnosis [Up to 1 week]
Results of cytological analysis of cerebrospinal fluid will be "Positive", "negative", "equivocal".

Secondary Outcome Measures

Proteomic profiles issued from cerebrospinal fluid [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".
Histological subtype [Before registration in study]
Histological subtype will be subdivised as invasive ductal breast carcinoma, invasive lobular breast carcinoma, other brest carcinoma.
Hormonal receptors status [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
Likehood of leptomeningeal metastasis according to the EANO-ESMO classification. [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.
Overall survival [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.
Proteomic profiles issued from blood [Up to 3 months after the intial diagnosis]
Proteomic profile will be obtained by bioinformatic analysis of blood.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Oscar Lambret	Lille	Hauts-de- France	France	59020
2	Centre Hospitalier Régional Universitaire de Lille	Lille	Hauts-de-France	France	59000

Sponsors and Collaborators

Centre Oscar Lambret

Investigators

Principal Investigator: Emilie LE RHUN, MD, Centre Oscar Lambret

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Oscar Lambret

ClinicalTrials.gov Identifier:

NCT03974204

Other Study ID Numbers:

Exo-LCR-1807
2018-A02358-47

First Posted:

Jun 4, 2019

Last Update Posted:

Oct 12, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Oscar Lambret

Cerebrospinal fluid

Proteomic profile

Additional relevant MeSH terms:

Breast Neoplasms

Neoplasm Metastasis

Meningeal Carcinomatosis

Study Results

No Results Posted as of Oct 12, 2021