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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
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.
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.
Centre Hospitalier Régional Universitaire de Lille
Lille, Hauts-de-France, France
Centre Oscar Lambret
Lille, Hauts-de-France, France
Proteomic profiles issued from cerebrospinal fluid at diagnosis
Proteomic profile will be obtained by bioinformatic analysis of cerebrospinal fluid.
Time frame: Up to 1 week
Cytology of cerebrospinal fluid at diagnosis
Results of cytological analysis of cerebrospinal fluid will be "Positive", "negative", "equivocal".
Time frame: Up to 1 week
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".
Time frame: Up to 3 months
Histological subtype
Histological subtype will be subdivised as invasive ductal breast carcinoma, invasive lobular breast carcinoma, other brest carcinoma.
Time frame: Before registration in study
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
Time frame: Before registration in study
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: Up to 3 months after the intial diagnosis
Overall survival
Overall survival is defined as time from date of registration to date of death regardless of the cause.
Time frame: Time from date of registration to date of death regardless of the cause, assessed up to 1 year
Proteomic profiles issued from blood
Proteomic profile will be obtained by bioinformatic analysis of blood.
Time frame: Up to 3 months after the intial diagnosis