ClinicalTrials.gg
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.

Primary conditionCentral Nervous System DiseasesRegistry: Nervous System DiseasesReclassifiedWhy we changed it
Registry
Nervous System Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Central Nervous System Diseases
Why
  1. The study's listed conditions name Central Nervous System Diseases, a narrower term within Nervous System Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Imagine Institute · Observational

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

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Conditions studied

  • Neurologic Disorder
  • Central Nervous System Diseases

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Keywords

  • Cerebrospinal Fluid
  • Central Nervous System Diseases
  • Neurologic Disorder
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In context

Central Nervous System Diseases Reclassified

386 studies on the registry are indexed under Central Nervous System Diseases; 104 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 139 across 73 observational studies indexed under Central Nervous System Diseases.

Browse Central Nervous System Diseases studies →

Lead sponsor

Imagine Institute is the lead sponsor of 31 studies on the registry; 15 are open to participants now.

Compared within Central Nervous System Diseases, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Nervous System Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.

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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

06

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

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Study locations

1 site
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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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 ↗

Not currently enrolling

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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