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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02358-47 | Other Identifier | N°ID RCB |
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Modification of the care habits. We believe today that we are no longer able to carry out this study as initially described.
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerebrospinal fluid and Blood sample collection | Experimental | Collection of cerebrospinal fluid and blood samples:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebrospinal fluid and blood sample collection at the initial diagnostic assessment | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proteomic profiles issued from cerebrospinal fluid at diagnosis | Proteomic profile will be obtained by bioinformatic analysis of cerebrospinal fluid. | Up to 1 week |
| Cytology of cerebrospinal fluid at diagnosis | Results of cytological analysis of cerebrospinal fluid will be "Positive", "negative", "equivocal". | Up to 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Proteomic profiles issued from cerebrospinal fluid | Proteomic profile will be obtained by bioinformatic analysis of cerebrospinal fluid:
| Up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emilie LE RHUN, MD | Centre Oscar Lambret | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Régional Universitaire de Lille | Lille | Hauts-de-France | 59000 | France | ||
| Centre Oscar Lambret |
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| Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "Lack of evidence" according to EANO-ESMO classification | Procedure | 3mL of cerebrospinal fluid and 10 ml of blood sample will be collected:
|
|
| Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "confirmed", "probable" or "possible", leading to leptomeningeal metastase specific treatment | Procedure | 3mL of cerebrospinal fluid and 10 ml of blood sample will be collected:
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| Histological subtype | Histological subtype will be subdivised as invasive ductal breast carcinoma, invasive lobular breast carcinoma, other brest carcinoma. | Before registration in study |
| Hormonal receptors status | Hormonal receptors status will be subdivised as:
| 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:
| 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 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. | Up to 3 months after the intial diagnosis |
| Lille |
| Hauts-de-France |
| 59020 |
| France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D055756 | Meningeal Carcinomatosis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011336 | Probability |
| ID | Term |
|---|---|
| D013223 | Statistics as Topic |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D055641 | Mathematical Concepts |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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