- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03974204
Analyses of Exosomes in the Cerebrospinal Fluid for Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.
Benefit of Analyzing Exosomes in the Cerebrospinal Fluid During the Medical Care of Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.
Study Overview
Status
Conditions
Intervention / Treatment
- Procedure: Cerebrospinal fluid and blood sample collection at the initial diagnostic assessment
- Procedure: Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "Lack of evidence" according to EANO-ESMO classification
- Procedure: Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "confirmed", "probable" or "possible", leading to leptomeningeal metastase specific treatment
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
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hauts-de- France
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Lille, Hauts-de- France, France, 59020
- Centre Oscar Lambret
-
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Hauts-de-France
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Lille, Hauts-de-France, France, 59000
- Centre Hospitalier Regional Universitaire de Lille
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cerebrospinal fluid and Blood sample collection
Collection of cerebrospinal fluid and blood samples:
|
At the initial diagnostic assessment, 3mL of cerebrospinal fluid and 10 ml of blood sample will be collected in order to determine the proteomic profile.
Cerebrospinal fluid will be collected during a lumbar puncture aiming to diagnose leptomeningeal metastases.
3mL of cerebrospinal fluid and 10 ml of blood sample will be collected:
3mL of cerebrospinal fluid and 10 ml of blood sample will be collected:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proteomic profiles issued from cerebrospinal fluid at diagnosis
Time Frame: Up to 1 week
|
Proteomic profile will be obtained by bioinformatic analysis of cerebrospinal fluid.
|
Up to 1 week
|
Cytology of cerebrospinal fluid at diagnosis
Time Frame: Up to 1 week
|
Results of cytological analysis of cerebrospinal fluid will be "Positive", "negative", "equivocal".
|
Up to 1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proteomic profiles issued from cerebrospinal fluid
Time Frame: Up to 3 months
|
Proteomic profile will be obtained by bioinformatic analysis of cerebrospinal fluid:
|
Up to 3 months
|
Histological subtype
Time Frame: Before registration in study
|
Histological subtype will be subdivised as invasive ductal breast carcinoma, invasive lobular breast carcinoma, other brest carcinoma.
|
Before registration in study
|
Hormonal receptors status
Time Frame: Before registration in study
|
Hormonal receptors status will be subdivised as:
|
Before registration in study
|
Likehood of leptomeningeal metastasis according to the EANO-ESMO classification.
Time Frame: Up to 3 months after the intial diagnosis
|
EANO-ESMO classification is obtained by searching clinical symptoms, cancer cells in the cerebrospinal fluid (obtained by lumbar puncture), signs in RMI. The likehood of leptomeningeal metastasis is:
|
Up to 3 months after the intial diagnosis
|
Overall survival
Time Frame: Time from date of registration to date of death regardless of the cause, assessed up to 1 year
|
Overall survival is defined as time from date of registration to date of death regardless of the cause.
|
Time from date of registration to date of death regardless of the cause, assessed up to 1 year
|
Proteomic profiles issued from blood
Time Frame: Up to 3 months after the intial diagnosis
|
Proteomic profile will be obtained by bioinformatic analysis of blood.
|
Up to 3 months after the intial diagnosis
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emilie Le Rhun, MD, Centre Oscar Lambret
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Exo-LCR-1807
- 2018-A02358-47 (Other Identifier: N°ID RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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