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

NCT07313098 | Not Yet Recruiting

• 1 other identifier: HJ-23-HJ-COLOCS
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurologic Disorder; Central Nervous System Diseases

Keywords

Cerebrospinal Fluid; Central Nervous System Diseases; Neurologic Disorder

Outcome Measures

Primary Outcomes (1)

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

  2021 - 2035

Secondary Outcomes (4)

• 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

Study Arms (1)

Patient

Patients with a neurological condition diagnosed by a physician and requiring CSF sampling as part of their routine care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Imagine Institute: lead

Study Sites (1)

Hôpital Necker-Enfants malades

Paris, 75015, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Leftover cerebrospinal fluid from medical procedures, residual blood samples

MeSH Terms

Conditions

Nervous System Diseases; Central Nervous System Diseases

Study Officials

• Marie-Louise FREMOND, Pr, MD

  Imagine Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Louise FREMOND, Pr, MD

CONTACT

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

Lelio GUIDA, Dr, MD

CONTACT

lelio.guida@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 31, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 1, 2036
• Study Completion (Estimated): January 1, 2036
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

FR (1)