Ignite Creation Date:
2024-05-06 @ 1:15 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03974204
Status:
WITHDRAWN
Last Update Posted:
2021-10-12
First Post:
2019-05-31
Brief Title:
Analyses of Exosomes in the Cerebrospinal Fluid for Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis
Sponsor:
Centre Oscar Lambret
Organization:
Centre Oscar Lambret
Study Overview
Official Title:
Benefit of Analyzing Exosomes in the Cerebrospinal Fluid During the Medical Care of Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis
Status:
WITHDRAWN
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Modification of the care habits We believe today that we are no longer able to carry out this study as initially described
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-A02358-47 | OTHER | NID RCB | None |