Pediatric Brain Tumor Foundation
Working to eliminate the challenges of childhood brain tumors

Cure the kids! Give Now

Analyses of Exosomes in the Cerebrospinal Fluid for Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender Female
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03974204
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre Oscar Lambret
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Emilie LE RHUN, MD
Principal Investigator Affiliation Centre Oscar Lambret
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Breast Cancer, Leptomeningeal Metastasis
Additional Details

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

Arms & Interventions

Arms

Experimental: 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.

Interventions

Procedure: - Cerebrospinal fluid and blood sample collection at the initial diagnostic assessment

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.

Procedure: - Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "Lack of evidence" according to EANO-ESMO classification

3mL of cerebrospinal fluid and 10 ml of blood sample will be collected: When suspected metastatic meningitis symptoms arise and at least 3 months after the initial diagnostic assessment, In order to determine the proteomic profile. Cerebrospinal fluid will be collected during a lumbar puncture aiming to diagnose leptomeningeal metastases.

Procedure: - Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "confirmed", "probable" or "possible", leading to leptomeningeal metastase specific treatment

3mL of cerebrospinal fluid and 10 ml of blood sample will be collected: 1 month after the beginning of the specific treatment, 3 months after the beginning of the specific treatment. Cerebrospinal fluid will be collected during a lumbar puncture aiming to assess treatment response or at intrathecal injection of treatment.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Centre Oscar Lambret, Lille, Hauts-de- France, France

Status

Address

Centre Oscar Lambret

Lille, Hauts-de- France, 59020

Site Contact

Emilie LE RHUN, MD

[email protected]

+33 (0)3 20 29 59 35

Lille, Hauts-de-France, France

Status

Address

Centre Hospitalier Régional Universitaire de Lille

Lille, Hauts-de-France, 59000

Site Contact

Emilie LE RHUN, MD

[email protected]

+33 (0)3 20 44 59 62