Cerebrospinal Fluid Proteome in Hydrocephalus

NCT ID: NCT02016352

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-12-31

Brief Summary

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PROLIPHYC is a collaborative prospective study that aims at discovering deep cerebrospinal fluid (CSF) proteome with a new clinically-compatible proteomics strategy, in a cohort of 100 patients suspected of neurodegenerative diseases and/or normal pressure hydrocephalus.

Detailed Description

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CSF proteome is the real time protein content that may reveal useful biomarkers for diagnosis and therapeutic decision-making. But the low protein concentration in CSF and the low volumes typically obtained after lumbar puncture precludes the conventional use of proteomic analysis. We miniaturized the method to be compatible with low-volume samples by combination of nanoLC-MS/MS analysis and combinatorial peptide ligand library technology to reduce the dynamic range of protein concentration in CSF and unmask previously undetected proteins. We demonstrated that this deep proteomic analysis allows profiling the CSF proteome with a reasonable depth, in short analytical times and good accuracy. We settled a clinically-compatible proteomics strategy targeting the deep CSF proteome discovery.

The PROLIPHYC study is a prospective study that aims at analysing CSF proteome with our new strategy in a cohort of patients suspected of normal pressure hydrocephalus and/or related neurodegenerative diseases. The PROLIPHYC project combines detailed clinical and neuropsychological evaluation, gait analysis, MRI brain imaging, lumbar CSF dynamics and deep proteome. We hypothesize in the PROLIPHYC study that a specific cluster of polypeptides can be associated with Alzheimer disease, vascular dementia and normal pressure hydrocephalus profiles. Validating this hypothesis might be a significant step towards a proteomic lexicon of aging brain, neurodegenerative diseases and dementia.

Neurosciences department and Alzheimer disease centre from the Toulouse University Hospital are both involved in this project. The deep proteomic study is performed in Toulouse by the Institute of Pharmacology and Structural Biology with the academic support of the Institute of Mathematics of Toulouse.

Conditions

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Normal Pressure Hydrocephalus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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patient

patient CSF extraction with hydrocephalus

Group Type EXPERIMENTAL

patient CSF extraction with hydrocephalus

Intervention Type BIOLOGICAL

CSF extraction

witness

patient without hydrocephalus but with peridural catheter for anesthetic. Witness CSF extraction has realized on catheter.

Group Type OTHER

witness CSF extraction

Intervention Type BIOLOGICAL

CSF extraction from patient not suffering from hydrocephalus

Interventions

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patient CSF extraction with hydrocephalus

CSF extraction

Intervention Type BIOLOGICAL

witness CSF extraction

CSF extraction from patient not suffering from hydrocephalus

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Gait problems, cognitive decline, urinary incontinence and enlarged ventricles on imaging

Exclusion Criteria

* Psychiatric disorders
* Lumbar punction contraindication
* RMI contraindication
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric SCHMIDT, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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Hospital

Toulouse, , France

Site Status

Countries

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France

References

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Guillotin S, Vallet A, Lorthois S, Cestac P, Schmidt E, Delcourt N. Association Between Homocysteine, Frailty and Biomechanical Response of the CNS in NPH-Suspected Patients. J Gerontol A Biol Sci Med Sci. 2022 Jul 5;77(7):1335-1343. doi: 10.1093/gerona/glac074.

Reference Type RESULT
PMID: 35325129 (View on PubMed)

Vallet A, Del Campo N, Hoogendijk EO, Lokossou A, Baledent O, Czosnyka Z, Balardy L, Payoux P, Swider P, Lorthois S, Schmidt E. Biomechanical response of the CNS is associated with frailty in NPH-suspected patients. J Neurol. 2020 May;267(5):1389-1400. doi: 10.1007/s00415-019-09689-z. Epub 2020 Jan 29.

Reference Type RESULT
PMID: 31997040 (View on PubMed)

Guillotin S, Fulzele A, Vallet A, de Peredo AG, Mouton-Barbosa E, Cestac P, Andrieu S, Burlet-Schiltz O, Delcourt N, Schmidt E. Cerebrospinal fluid proteomic profile of frailty: Results from the PROLIPHYC cohort. Aging Cell. 2024 Jul;23(7):e14168. doi: 10.1111/acel.14168. Epub 2024 May 2.

Reference Type RESULT
PMID: 38698559 (View on PubMed)

Other Identifiers

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2011-A01091-40

Identifier Type: OTHER

Identifier Source: secondary_id

10 045 08

Identifier Type: -

Identifier Source: org_study_id

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