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Not yet recruiting NCT07313098

Longitudinal Assessment of Protein Markers in the Cerebrospinal Fluid of Patients With Central Nervous System Involvement

Observational Neurologic Disorder Central Nervous System Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Neurologic Disorder, Central Nervous System Diseases. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

In the context of adult pathology, research into biomarkers in cerebrospinal fluid (CSF) has already identified proteins that are commonly used for the early diagnosis of certain neurodegenerative diseases. However, the lack of data available in the literature on pediatric diseases has limited the use of biomarkers in routine practice in children. Importantly, our group has pioneered the establishment of CSF biomarkers in children (e.g., measurement of interferon alpha in CSF by ultra-sensitive digital ELISA), which will undoubtedly be used in routine clinical practice in the future. In light of these arguments, the establishment of a CSF biobank will have major clinical implications, given the rarity of the diseases treated and the number of patients followed.

Primary outcome measures

  • Longitudinal evolution of protein markers in CSF from patients with central nervous system involvement [Time frame: 2021 - 2035]
Secondary outcome measures (4)
  • Longitudinal changes in inflammatory protein levels in the CSF of patients with post-hemorrhagic hydrocephalus [Time frame: 2021 - 2035]
  • Proteomic characterization of several neuroinflammatory diseases [Time frame: 2021 - 2035]
  • Identification of biomarkers of severity in children with traumatic brain injury [Time frame: 2021 - 2035]
  • Comparison of CSF biomarkers with data generated in serum (when available) [Time frame: 2021 - 2035]

Eligibility criteria

Inclusion criteria

  • Patients with a neurological condition diagnosed by a physician requiring cerebrospinal fluid (CSF) collection, through:
  • Neurosurgical procedure (EVD, VP shunt, VSG shunt, tumor surgery, spinal surgery with dural opening, ELD);
  • Lumbar puncture (LP).
  • Patients who have (or whose legal guardians, where applicable, have) consented to the storage and reuse of residual biological samples collected during the course of care within the biological collection.

Exclusion criteria

1\. Objection by the patient and/or the legal guardian, if the patient is a minor, to participation in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hôpital Necker-Enfants malades — Paris

Identifiers

NCT: NCT07313098 · HJ-23-HJ-COLOCS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗