Longitudinal Assessment of Protein Markers in the Cerebrospinal Fluid of Patients With Central Nervous System Involvement (HJ-COLOCS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Central Nervous System Diseases; Neurologic Disorder

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Marie-Louise FREMOND, Pr, MD; Phone Number: +33 1 42 75 44 43; Email: marie-louise.fremond@institutimagine.org
• Study Contact Backup: Name: Lelio GUIDA, Dr, MD; Email: lelio.guida@aphp.fr

Study Locations

• France
  • Paris, France, 75015
    • Hôpital Necker-Enfants Malades
    • Principal Investigator: Marie-Louise FREMOND, Pr
    • Contact: Marie-Louise FREMOND, Pr; Phone Number: +33 1 44 49 48 24; Email: marie-louise.fremond@aphp.fr
    • Contact: Lelio GUIDA, Dr; Email: lelio.guida@aphp.fr
    • Sub-Investigator: Lelio GUIDA, Dr
    • Sub-Investigator: Thomas BLAUWBLOMME, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a neurological condition diagnosed by a physician requiring cerebrospinal fluid (CSF) collection as a part of their health care

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patient; Patients with a neurological condition diagnosed by a physician and requiring CSF sampling as part of their routine care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Proteomic analysis by comparing LCS biomarker results with data generated in serum, in order to discover new biomarkers relevant to the pathology under study.	2021 - 2035

Collaborators and Investigators

• Sponsor: Imagine Institute
• Investigators: Principal Investigator: Marie-Louise FREMOND, Pr, MD, Imagine Institute

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): January 1, 2036
• Study Completion (Estimated): January 1, 2036

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Central Nervous System Diseases; Cerebrospinal Fluid; Neurologic Disorder
• Additional Relevant MeSH Terms: Nervous System Diseases; Central Nervous System Diseases
• Other Study ID Numbers: HJ-23-HJ-COLOCS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No