Benefit of Analyzing Exosomes in the Cerebrospinal Fluid During the Medical Care of Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Proteomic profiles issued from cerebrospinal fluid at diagnosis
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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 leptomeningitis
- •Age ≥ 18 years
- •Patient covered by the French social security regime
- •Signed written informed consent
排除标准
- •History of cancer other than the one being treated
- •Contraindication to carrying out the lumbar puncture or cerebrospinal MRI
- •Pregnant or breastfeeding patient
研究组 & 干预措施
Cerebrospinal fluid and Blood sample collection
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.
干预措施: Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "confirmed", "probable" or "possible", leading to leptomeningeal metastase specific treatment (Procedure)
Cerebrospinal fluid and Blood sample collection
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.
干预措施: Cerebrospinal fluid and blood sample collection at the initial diagnostic assessment (Procedure)
Cerebrospinal fluid and Blood sample collection
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.
干预措施: Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "Lack of evidence" according to EANO-ESMO classification (Procedure)
结局指标
主要结局
Proteomic profiles issued from cerebrospinal fluid at diagnosis
时间窗: Up to 1 week
Proteomic profile will be obtained by bioinformatic analysis of cerebrospinal fluid.
Cytology of cerebrospinal fluid at diagnosis
时间窗: Up to 1 week
Results of cytological analysis of cerebrospinal fluid will be "Positive", "negative", "equivocal".
次要结局
- 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)