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Not yet recruitingNCT07313098HJ-COLOCSUpdated Sep 9, 2026

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

An observational study in Neurologic Disorder and Central Nervous System Diseases, sponsored by Imagine Institute. Not yet recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Imagine Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,000
Sex
All
01

Study 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.

02

Conditions studied

  • Neurologic Disorder
  • Central Nervous System Diseases

Keywords

  • Cerebrospinal Fluid
  • Central Nervous System Diseases
  • Neurologic Disorder
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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

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

Exclusion Criteria:

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

04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Patient

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

05

What researchers measure

Primary outcomes

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

    Time frame: 2021 - 2035

Secondary outcomes

  1. Longitudinal changes in inflammatory protein levels in the CSF of patients with post-hemorrhagic hydrocephalus

    Time frame: 2021 - 2035

  2. Proteomic characterization of several neuroinflammatory diseases

    Time frame: 2021 - 2035

  3. Identification of biomarkers of severity in children with traumatic brain injury

    Time frame: 2021 - 2035

  4. 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.

    Time frame: 2021 - 2035

06

Study locations

1 site
  • Hôpital Necker-Enfants malades
    Paris, 75015, France
    • Marie-Louise FREMOND, Pr · Contact · marie-louise.fremond@aphp.fr · +33 1 44 49 48 24
    • Lelio GUIDA, Dr · Contact · lelio.guida@aphp.fr
    • Marie-Louise FREMOND, Pr · Principal investigator
    • Lelio GUIDA, Dr · Sub investigator
    • Thomas BLAUWBLOMME, Pr · Sub investigator
07

Registry details

Key details

Study ID
NCT07313098
Lead sponsor
Imagine Institute
Responsible party
Sponsor
First posted
Dec 31, 2025
Start date
Jan 1, 2027 (estimated)
Primary completion
Jan 1, 2036 (estimated)
Completion
Jan 1, 2036 (estimated)
Last update
Sep 9, 2026

Study contacts

Marie-Louise FREMOND, Pr, MD
Contact
marie-louise.fremond@institutimagine.org
+33 1 42 75 44 43
Lelio GUIDA, Dr, MD
Contact
lelio.guida@aphp.fr
Marie-Louise FREMOND, Pr, MD
principal investigator · Imagine Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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