The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: 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 ID: NCT03974204
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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Centre Oscar Lambret, Lille, Hauts-de- France, France
Centre Hospitalier Régional Universitaire de Lille, Lille, Hauts-de-France, France
Name: Emilie LE RHUN, MD
Affiliation: Centre Oscar Lambret
Role: PRINCIPAL_INVESTIGATOR