Breast Cancer, Leptomeningeal Metastasis
Conditions
Keywords
Cerebrospinal fluid, Proteomic profile
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.
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
Interventions
PROCEDURECerebrospinal 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.
PROCEDURECerebrospinal 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.
PROCEDURECerebrospinal 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.
Sponsors
Centre Oscar Lambret
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Histological subtype | Before registration in study | Histological subtype will be subdivised as invasive ductal breast carcinoma, invasive lobular breast carcinoma, other brest carcinoma. |
| Proteomic profiles issued from blood | Up to 3 months after the intial diagnosis | Proteomic profile will be obtained by bioinformatic analysis of blood. |
| 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. |
| 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 |
Countries
France
Outcome results
None listed