Clinical trial NCT03974204: Analyses of Exosomes in the Cerebrospinal Fluid for Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.
Official title: Benefit of Analyzing Exosomes in the Cerebrospinal Fluid During the Medical Care of Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Leptomeningeal Metastasis
Keywords: Cerebrospinal fluid
Proteomic profile
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Proteomic profiles issued from cerebrospinal fluid at diagnosis
timeFrame: Up to 1 week
measure: Cytology of cerebrospinal fluid at diagnosis
timeFrame: Up to 1 week
Secondary outcomes:
measure: Proteomic profiles issued from cerebrospinal fluid
timeFrame: Up to 3 months
measure: Histological subtype
timeFrame: Before registration in study
measure: Hormonal receptors status
timeFrame: Before registration in study
measure: Likehood of leptomeningeal metastasis according to the EANO-ESMO classification.
timeFrame: Up to 3 months after the intial diagnosis
measure: Overall survival
timeFrame: Time from date of registration to date of death regardless of the cause, assessed up to 1 year
measure: Proteomic profiles issued from blood
timeFrame: Up to 3 months after the intial diagnosis
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
state: Hauts-de- France
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille
state: Hauts-de-France
Study officials:
affiliation: Centre Oscar Lambret
name: Emilie LE RHUN, MD
role: PRINCIPAL_INVESTIGATOR
References: