Feasibility of Exosome Analysis in Cerebrospinal Fluid During the Diagnostic Workup of Metastatic Meningitis From Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- cytological analysis of the CSF
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •History of another cancer than the one for which the patient is referred;
- •Contraindication to lumbar puncture or cerebrospinal MRI
- •Pregnant or breastfeeding woman
研究组 & 干预措施
Study process
Consultation, Cerebral and medullary MRI, lumbar puncture, CSF sampling, blood sample, collection of breast fluid
干预措施: Consultation (Procedure)
Study process
Consultation, Cerebral and medullary MRI, lumbar puncture, CSF sampling, blood sample, collection of breast fluid
干预措施: Cerebral and medullary MRI, lumbar puncture, CSF sampling (Procedure)
Study process
Consultation, Cerebral and medullary MRI, lumbar puncture, CSF sampling, blood sample, collection of breast fluid
干预措施: biological test (Biological)
结局指标
主要结局
cytological analysis of the CSF
时间窗: 36 months
The cytological analysis of the CSF will allow to obtain 3 possible results: Positive / Negative / Equivocal at the time of the initial diagnostic workup for all patients and in case of renewal of the initial LP if the 1st one was not exploitable for the cytological analysis of the CSF, for all patients.
CSF protein composition
时间窗: 36 months
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.
次要结局
未报告次要终点