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Trial record 1 of 155 for:    Hydrocephalus
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Cerebrospinal Fluid Proteome in Hydrocephalus (PROLIPHYC)

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ClinicalTrials.gov Identifier: NCT02016352
Recruitment Status : Completed
First Posted : December 20, 2013
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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
Normal Pressure Hydrocephalus Biological: patient CSF extraction with hydrocephalus Biological: witness CSF extraction

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 Type : Interventional  (Clinical Trial)
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 : March 2013
Primary Completion Date : September 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: patient
patient CSF extraction with hydrocephalus
Biological: patient CSF extraction with hydrocephalus
CSF extraction
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



Primary Outcome Measures :
  1. CSF proteome measure [ Time Frame: 48 hours ]
    CSF extraction (3 ml)


Secondary Outcome Measures :
  1. correlation between CSF proteome and gait analysis [ Time Frame: 72 hours ]
    compare results from CSF proteome and gait analysis

  2. correlation between CSF proteome and MRI brain imaging [ Time Frame: 72 hours ]
    compare results from CSF proteome and brain imaging



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Psychiatric disorders
  • Lumbar punction contraindication
  • RMI contraindication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016352


Locations
France
Hospital
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Eric SCHMIDT, MD PhD University Hospital, Toulouse

Publications:
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02016352     History of Changes
Other Study ID Numbers: 10 045 08
2011-A01091-40 ( Other Identifier: AFSSAPS ID-RCB )
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital, Toulouse:
hydrocephalus
proteomic
cerebrospinal fluid

Additional relevant MeSH terms:
Hydrocephalus
Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases