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Cerebrospinal Fluid Proteome in Hydrocephalus (PROLIPHYC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University Hospital, Toulouse
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT02016352
First received: June 18, 2013
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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 Intervention
Normal Pressure Hydrocephalus
Biological: patient CSF extraction with hydrocephalus
Biological: witness CSF extraction from patient not suffering from hydrocephalus

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Cerebrospinal Fluid Proteome in Hydrocephalus

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • CSF proteome measure [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    CSF extraction (3 ml)


Secondary Outcome Measures:
  • correlation between CSF proteome and gait analysis [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    compare results from CSF proteome and gait analysis

  • correlation between CSF proteome and MRI brain imaging [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    compare results from CSF proteome and brain imaging


Estimated Enrollment: 120
Study Start Date: March 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: patient
CSF is taken from patients with hydrocephalus
Biological: patient CSF extraction with hydrocephalus
CSF extraction
witness
CSF extraction from patients that do not suffer from hydrocephalus
Biological: witness CSF extraction from patient not suffering from hydrocephalus
CSF extraction from patient not suffering from hydrocephalus

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02016352

Contacts
Contact: ERIC SCHMIDT, MD PhD 33561779381 ext 33 schmidt.e@chu-toulouse.fr
Contact: CECILE GAUCHET, PhD 33561778496 ext 33 gauchet.c@chu-toulouse.fr

Locations
France
Hospital Recruiting
Toulouse, France, 31059
Contact: Cécile Gauchet, PhD    33561778496 ext 33    gauchet.c@chu-toulouse.fr   
Contact: Eric Schmidt, MD PhD    33561779381 ext 33    schmidt.e@chu-toulouse.fr   
Principal Investigator: Eric Schmidt, MD PhD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Eric SCHMIDT, MD PhD University Hospital, Toulouse
  More Information

Publications:
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02016352     History of Changes
Other Study ID Numbers: 10 045 08, 2011-A01091-40
Study First Received: June 18, 2013
Last Updated: July 22, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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
Intracranial Hypertension

ClinicalTrials.gov processed this record on August 28, 2014