Neurologic DisorderHJ-COLOCSNCT07313098
Longitudinal Assessment of Protein Markers in the Cerebrospinal Fluid of Patients With Central Nervous System Involvement
An observational study of Neurologic Disorder and Central Nervous System Diseases, run by Imagine Institute at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neurologic Disorder, Central Nervous System Diseases
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2027to 1 Jan 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a neurological condition diagnosed by a physician requiring cerebrospinal fluid (CSF) collection as a part of their health care
Who may be able to join
- 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.
Who cannot join
- 1. Objection by the patient and/or the legal guardian, if the patient is a minor, to participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lelio GUIDA, Dr, MD contact
France1 site
Hôpital Necker-Enfants malades
Paris, 75015
Marie-Louise FREMOND, Pr, +33 1 44 49 48 24, marie-louise.fremond@aphp.fr
Lelio GUIDA, Dr, lelio.guida@aphp.fr
About this study
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.
- Keywords
- Cerebrospinal Fluid, Central Nervous System Diseases, Neurologic Disorder
- Medical subject headings
- Nervous System Diseases, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Patients with a neurological condition diagnosed by a physician and requiring CSF sampling as part of their routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal evolution of protein markers in CSF from patients with central nervous system involvement
Measured: 2021 - 2035
Secondary outcomes (4)
Longitudinal changes in inflammatory protein levels in the CSF of patients with post-hemorrhagic hydrocephalus
Measured: 2021 - 2035
Proteomic characterization of several neuroinflammatory diseases
Measured: 2021 - 2035
Identification of biomarkers of severity in children with traumatic brain injury
Measured: 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.
Measured: 2021 - 2035
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2036 (estimated)
- Study completion1 Jan 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imagine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Louise FREMOND, Pr, MD, Principal investigator, Imagine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313098
- Sponsor's protocol ID
- HJ-23-HJ-COLOCS
- Acronym
- HJ-COLOCS
- Status last verified
- Sep 2026
- First submitted
- 18 Nov 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Protein Markers in the Cerebrospinal Fluid of Patients With Central Nervous System Involvement
- ClinicalTrials.gov ID
- NCT07313098
- Acronym / sponsor ID
- HJ-COLOCS / HJ-23-HJ-COLOCS
- Keywords
- Cerebrospinal Fluid, Central Nervous System Diseases, Neurologic Disorder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Imagine InstituteUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2036 (estimated)
- Study completion
- 1 Jan 2036 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | – | –Patients with a neurological condition diagnosed by a physician and requiring CSF sampling as part of their routine care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a neurological condition diagnosed by a physician requiring cerebrospinal fluid (CSF) collection as a part of their health care
Key inclusion criteria (4 listed)
- Patients with a neurological condition diagnosed by a physician requiring cerebrospinal fluid (CSF) collection, through:
- 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.
Key exclusion criteria (1 listed)
- 1. Objection by the patient and/or the legal guardian, if the patient is a minor, to participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Longitudinal evolution of protein markers in CSF from patients with central nervous system involvement
Time frame: 2021 - 2035
4 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lelio GUIDA, Dr, MD contact
Marie-Louise FREMOND, Pr, MD principal investigator
Imagine Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurologic Disorder and Central Nervous System Diseases, run by Imagine Institute at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Louise FREMOND, Pr, MD (+33 1 42 75 44 43, marie-louise.fremond@institutimagine.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal evolution of protein markers in CSF from patients with central nervous system involvement (time frame: 2021 - 2035). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.