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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07313098

Acronym

HJ-COLOCS

Enrollment

1000

Registered

2025-12-31

Start date

2027-01-01

Completion date

2036-01-01

Last updated

2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Nervous System Diseases, Neurologic Disorder

Keywords

Cerebrospinal Fluid, Central Nervous System Diseases, Neurologic Disorder

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

1. 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). 2. 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.

Design outcomes

Primary

Measure	Time frame
Longitudinal evolution of protein markers in CSF from patients with central nervous system involvement	2021 - 2035

Secondary

Measure	Time frame	Description
Longitudinal changes in inflammatory protein levels in the CSF of patients with post-hemorrhagic hydrocephalus	2021 - 2035	—
Proteomic characterization of several neuroinflammatory diseases	2021 - 2035	—
Identification of biomarkers of severity in children with traumatic brain injury	2021 - 2035	—
Comparison of CSF biomarkers with data generated in serum (when available)	2021 - 2035	Proteomic analysis by comparing LCS biomarker results with data generated in serum, in order to discover new biomarkers relevant to the pathology under study.

Countries

France

Contacts

CONTACTMarie-Louise FREMOND, Pr, MD

marie-louise.fremond@institutimagine.org+33 1 42 75 44 43

CONTACTLelio GUIDA, Dr, MD

lelio.guida@aphp.fr

PRINCIPAL_INVESTIGATORMarie-Louise FREMOND, Pr, MD

Imagine Institute

Outcome results