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NCT Number: NCT07313098

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

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.

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Key information

Conditions

Neurologic Disorder Central Nervous System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Necker-Enfants malades

Paris, 75015, France

Location contact

Lelio GUIDA, Dr

CONTACT

[email protected]

Lelio GUIDA, Dr

SUB_INVESTIGATOR

Marie-Louise FREMOND, Pr

CONTACT

[email protected]

+33 1 44 49 48 24

Marie-Louise FREMOND, Pr

PRINCIPAL_INVESTIGATOR

Thomas BLAUWBLOMME, Pr

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

Longitudinal evolution of protein markers in CSF from patients with central nervous system involvement

Time frame: 2021 - 2035

Secondary outcomes

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

Proteomic analysis by comparing LCS biomarker results with data generated in serum, in order to discover new biomarkers relevant to the pathology under study.

Study contacts

Contact information is provided by the study sponsor or research team.

Lelio GUIDA, Dr, MD

CONTACT

[email protected]

Marie-Louise FREMOND, Pr, MD

CONTACT

[email protected]

+33 1 42 75 44 43

Sponsors and collaborators

Lead sponsor

Imagine Institute

Other

Registry information

Acronym: HJ-COLOCS

Important dates

Study start: 2026
Primary completion: 2036
Study completion: 2036
First posted: Dec 31, 2025
Registry last updated: Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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