Clinical trial · Interventional
Feasibility of Exosome Analysis in Cerebrospinal Fluid During the Diagnostic Workup of Metastatic Meningitis
Feasibility of Exosome Analysis in Cerebrospinal Fluid During the Diagnostic Workup of Metastatic Meningitis From Breast Cancer
NCT05286684CI-TRIAL-00105857Exo-LCRcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators are interested in one of the most frequent tumor types causing leptomeningeal metastasis in order to investigate whether a profile can be established by a high-throughput clinical proteomic approach. All the data acquired will allow a tailored and promising approach to improve the knowledge of metastatic tumor meningitis.
Conditions
Conditions (1)
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 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biological test | Biological | — | UNRESOLVED |
| Cerebral and medullary MRI, lumbar puncture, CSF sampling | Procedure | — | UNRESOLVED |
| Consultation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study process
- description
- Consultation, Cerebral and medullary MRI, lumbar puncture, CSF sampling, blood sample, collection of breast fluid
- interventionNames
- Procedure: Consultation
- Procedure: Cerebral and medullary MRI, lumbar puncture, CSF sampling
- Biological: biological test
Primary outcomes (2)
- measure
- CSF protein composition
- timeFrame
- 36 months
- description
- The CSF proteomic profile will be obtained by an unsupervised bioinformatics analysis of the CSF collected during the initial diagnostic workup for all patients and in case of renewal of the initial lumbar puncture if the 1st one was not exploitable for the CSF cytological analysis. The bioinformatics analysis will allow to obtain the protein composition and to establish proteomic profile.
- measure
- cytological analysis of the CSF
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 leptomeningeal involvement; * Age ≥ 18 ans ; * WHO performance status ≤ 2 ; * Affiliation to the National Social Security System ; * With informed and signed consent Exclusion Criteria: * History of another cancer than the one for which the patient is referred; * Contraindication to lumbar puncture or cerebrospinal MRI * Pregnant or breastfeeding woman
References
Publications (0)
Data not yet available
No reference posted for this study.