PROLIPHYC: Cerebrospinal Fluid Proteome in Hydrocephalus

• Sponsor: University Hospital, Toulouse (Other)
• Overall Status: Completed
• CT.gov ID: NCT02016352
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 33
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Normal Pressure Hydrocephalus	Biological: patient CSF extraction with hydrocephalus; Biological: witness CSF extraction	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Cerebrospinal Fluid Proteome in Hydrocephalus
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: patient patient CSF extraction with hydrocephalus	Biological: patient CSF extraction with hydrocephalus; CSF extraction
Other: witness patient without hydrocephalus but with peridural catheter for anesthetic. Witness CSF extraction has realized on catheter.	Biological: witness CSF extraction; CSF extraction from patient not suffering from hydrocephalus

Outcome Measures

Primary Outcome Measures

1. CSF proteome measure [48 hours]

   CSF extraction (3 ml)

Secondary Outcome Measures

1. correlation between CSF proteome and gait analysis [72 hours]

   compare results from CSF proteome and gait analysis

2. correlation between CSF proteome and MRI brain imaging [72 hours]

   compare results from CSF proteome and brain imaging

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• Psychiatric disorders

• Lumbar punction contraindication

• RMI contraindication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital	Toulouse		France	31059

Sponsors and Collaborators

• University Hospital, Toulouse

Investigators

• Principal Investigator: Eric SCHMIDT, MD PhD, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

• Bech-Azeddine R, Høgh P, Juhler M, Gjerris F, Waldemar G. Idiopathic normal-pressure hydrocephalus: clinical comorbidity correlated with cerebral biopsy findings and outcome of cerebrospinal fluid shunting. J Neurol Neurosurg Psychiatry. 2007 Feb;78(2):157-61. Epub 2006 Sep 29.

• Responsible Party: University Hospital, Toulouse
• ClinicalTrials.gov Identifier: NCT02016352
• Other Study ID Numbers: 10 045 08; 2011-A01091-40
• First Posted: Dec 20, 2013
• Last Update Posted: Nov 10, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by University Hospital, Toulouse: hydrocephalus; proteomic; cerebrospinal fluid
• Additional relevant MeSH terms: Hydrocephalus; Hydrocephalus, Normal Pressure

Study Results

No Results Posted as of Nov 10, 2020