Clinical trial · Interventional
Analyses of Exosomes in the Cerebrospinal Fluid for Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.
Benefit of Analyzing Exosomes in the Cerebrospinal Fluid During the Medical Care of Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Modification of the care habits. We believe today that we are no longer able to carry out this study as initially described.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Leptomeningeal Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cerebrospinal fluid and blood sample collection at the initial diagnostic assessment | Procedure | — | UNRESOLVED |
| Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "confirmed", "probable" or "possible", leading to leptomeningeal metastase specific treatment | Procedure | — | UNRESOLVED |
| Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "Lack of evidence" according to EANO-ESMO classification | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cerebrospinal fluid and Blood sample collection
- description
- Collection of cerebrospinal fluid and blood samples: * At initial diagnostic assessment; * 1 month and 3 months after initial diagnostic assessment, for patients classified "possible", "probable" or "confirmed" according to EANO-ESMO classification, leading to specific leptomeningeal metastase treatment; * In case of symptoms leading to leptomeningeal metastase suspicion and at least 3 months after diagnostic assessment, for patients classified "lack of evidence" according to EANO-ESMO classification.
- interventionNames
- Procedure: Cerebrospinal fluid and blood sample collection at the initial diagnostic assessment
- Procedure: Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "Lack of evidence" according to EANO-ESMO classification
- Procedure: Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "confirmed", "probable" or "possible", leading to leptomeningeal metastase specific treatment
Primary outcomes (2)
- measure
- Proteomic profiles issued from cerebrospinal fluid at diagnosis
- timeFrame
- Up to 1 week
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available