Benefit of Analyzing Exosomes in the Cerebrospinal Fluid During the Medical Care of Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Centre Oscar Lambret
- Locations
- 4
- Primary Endpoint
- Cytology of cerebrospinal fluid at diagnosis
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
Cytology of cerebrospinal fluid at diagnosis
Time Frame: Up to 1 week
Results of cytological analysis of cerebrospinal fluid will be "Positive", "negative", "equivocal".
Proteomic profiles issued from cerebrospinal fluid at diagnosis
Time Frame: Up to 1 week
Proteomic profile will be obtained by bioinformatic analysis of cerebrospinal fluid.
Secondary Outcomes
- Likehood of leptomeningeal metastasis according to the EANO-ESMO classification.(Up to 3 months after the intial diagnosis)
- Proteomic profiles issued from cerebrospinal fluid(Up to 3 months)
- Overall survival(Time from date of registration to date of death regardless of the cause, assessed up to 1 year)
- Histological subtype(Before registration in study)
- Hormonal receptors status(Before registration in study)
- Proteomic profiles issued from blood(Up to 3 months after the intial diagnosis)