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

Breast Cancer Clinical Trial

Official title:

Benefit of Analyzing Exosomes in the Cerebrospinal Fluid During the Medical Care of Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03974204
• Other study ID #: Exo-LCR-1807
• Secondary ID: 2018-A02358-47
• Status: Withdrawn
• Phase: N/A
• Start date: July 2019
• Est. completion date: October 2023

Study information

• Verified date: October 2021
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Leptomeningeal Metastasis
• Meningeal Carcinomatosis
• Neoplasm Metastasis

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire de Lille	Lille	Hauts-de-France
France	Centre Oscar Lambret	Lille	Hauts-de- France

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proteomic profiles issued from cerebrospinal fluid at diagnosis	Proteomic profile will be obtained by bioinformatic analysis of cerebrospinal fluid.	Up to 1 week
Primary	Cytology of cerebrospinal fluid at diagnosis	Results of cytological analysis of cerebrospinal fluid will be "Positive", "negative", "equivocal".	Up to 1 week
Secondary	Proteomic profiles issued from cerebrospinal fluid	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".	Up to 3 months
Secondary	Histological subtype	Histological subtype will be subdivised as invasive ductal breast carcinoma, invasive lobular breast carcinoma, other brest carcinoma.	Before registration in study
Secondary	Hormonal receptors status	Hormonal receptors status will be subdivised as: Positive hormonal receptors / Positive HER2; Positive hormonal receptors / Negative HER2; Negative hormonal receptors / Positive HER2; Triple negative	Before registration in study
Secondary	Likehood of leptomeningeal metastasis according to the EANO-ESMO classification.	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.	Up to 3 months after the intial diagnosis
Secondary	Overall survival	Overall survival is defined as time from date of registration to date of death regardless of the cause.	Time from date of registration to date of death regardless of the cause, assessed up to 1 year
Secondary	Proteomic profiles issued from blood	Proteomic profile will be obtained by bioinformatic analysis of blood.	Up to 3 months after the intial diagnosis