Trials / Completed
CompletedNCT05286684
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- Centre Oscar Lambret · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
The primary objective is to describe on an exploratory basis the association between the type of proteomic profile from cerebrospinal fluid (CSF) microvesicles (from unsupervised bioinformatics analysis) and CSF cytology analysis (positive, negative, equivocal) in breast cancer patients with suspected leptomeningeal metastases, on initial CSF samples (hereafter referred to as initial proteomic profile and initial cytology).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Consultation | History of the disease, anatomopathological and molecular biological data concerning the initial tumor; Collection of treatments received and/or in progress by the patient for her meningeal tumor (chemotherapy, targeted therapy, radiotherapy, surgery, corticosteroids, antiepileptics); Evaluation of the general condition and neurological status. |
| PROCEDURE | Cerebral and medullary MRI, lumbar puncture, CSF sampling | diagnosis of leptomeningeal involvement |
| BIOLOGICAL | biological test | 5 ml of additional CSF after diagnostic lumbar puncture for proteomic analysis, 50-100 µl of breast aspiration fluid (NAF) for patients with an existing breast tumor, for proteomic analysis 10 ml of blood for proteomic analysis |
Timeline
- Start date
- 2023-01-04
- Primary completion
- 2023-11-15
- Completion
- 2023-11-15
- First posted
- 2022-03-18
- Last updated
- 2026-03-18
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05286684. Inclusion in this directory is not an endorsement.