NCT05286684

Brief Summary

The investigators are interested in one of the most frequent tumor types causing leptomeningeal metastasis in order to investigate whether a profile can be established by a high-throughput clinical proteomic approach. All the data acquired will allow a tailored and promising approach to improve the knowledge of metastatic tumor meningitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

January 4, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

January 31, 2022

Last Update Submit

March 16, 2026

Conditions

Breast Cancer

Keywords

leptomeningeal metastasesproteomic profilecerebrospinal fluidcytology analysis

Outcome Measures

Primary Outcomes (2)

  • CSF protein composition

    The CSF proteomic profile will be obtained by an unsupervised bioinformatics analysis of the CSF collected during the initial diagnostic workup for all patients and in case of renewal of the initial lumbar puncture if the 1st one was not exploitable for the CSF cytological analysis. The bioinformatics analysis will allow to obtain the protein composition and to establish proteomic profile.

    36 months

  • cytological analysis of the CSF

    The cytological analysis of the CSF will allow to obtain 3 possible results: Positive / Negative / Equivocal at the time of the initial diagnostic workup for all patients and in case of renewal of the initial LP if the 1st one was not exploitable for the cytological analysis of the CSF, for all patients.

    36 months

Study Arms (1)

Study process

EXPERIMENTAL

Consultation, Cerebral and medullary MRI, lumbar puncture, CSF sampling, blood sample, collection of breast fluid

Procedure: ConsultationProcedure: Cerebral and medullary MRI, lumbar puncture, CSF samplingBiological: biological test

Interventions

ConsultationPROCEDURE

History of the disease, anatomopathological and molecular biological data concerning the initial tumor; Collection of treatments received and/or in progress by the patient for her meningeal tumor (chemotherapy, targeted therapy, radiotherapy, surgery, corticosteroids, antiepileptics); Evaluation of the general condition and neurological status.

Study process
Cerebral and medullary MRI, lumbar puncture, CSF samplingPROCEDURE

diagnosis of leptomeningeal involvement

Study process
biological testBIOLOGICAL

5 ml of additional CSF after diagnostic lumbar puncture for proteomic analysis, 50-100 µl of breast aspiration fluid (NAF) for patients with an existing breast tumor, for proteomic analysis 10 ml of blood for proteomic analysis

Study process

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBreast cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with histologically proven breast cancer;
  • Patient with suspected metastatic leptomeningeal involvement;
  • Age ≥ 18 ans ;
  • WHO performance status ≤ 2 ;
  • Affiliation to the National Social Security System ;
  • With informed and signed consent

You may not qualify if:

  • History of another cancer than the one for which the patient is referred;
  • Contraindication to lumbar puncture or cerebrospinal MRI
  • Pregnant or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Oscar Lambret

Lille, Hauts-de-France, 59000, France

Location

MeSH Terms

Conditions

Breast NeoplasmsMeningeal Carcinomatosis

Interventions

Referral and ConsultationSpinal Puncture

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesMeningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNervous System Diseases

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services AdministrationBiopsySpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Claire Cheymol, MD

    Centre Oscar Lambret

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2022

First Posted

March 18, 2022

Study Start

January 4, 2023

Primary Completion

November 15, 2023

Study Completion

November 15, 2023

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)