Cerebrospinal Fluid Proteome in Hydrocephalus

Status Completed

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02016352
Study type	Interventional
Source	University Hospital, Toulouse
Contact
Status	Completed
Phase	N/A
Start date	March 2013
Completion date	December 2015

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT00149721` - Anterior Pituitary Function in Patients With Hydrocephalus	N/A
Completed	`NCT00196196` - A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.	Phase 3
Not yet recruiting	`NCT05562596` - Normal Pressure Hydrocephalus Biomarkers Investigation
Unknown status	`NCT00874198` - European Study on Prediction of Outcome in Patients With Idiopathic Normal Pressure Hydrocephalus	N/A
Completed	`NCT00233701` - Normal Pressure Hydrocephalus (NPH) Registry	Phase 4
Withdrawn	`NCT00793416` - ShuntCheck Accuracy in Detecting Shunt Obstruction Normal Pressure Hydrocephalus (NPH) Patients	Phase 4
Recruiting	`NCT05910944` - European Study of Prodromal iNPH
Active, not recruiting	`NCT01909960` - Flow MRI in Normal Pressure Hydrocephalus	N/A
Terminated	`NCT01092546` - Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus	Phase 3
Terminated	`NCT00613886` - Factors Predicting Response to Shunting in Normal Pressure Hydrocephalus	N/A
Completed	`NCT01815775` - Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery	Phase 0
Recruiting	`NCT03877107` - Effect of Depletive Lumbar Puncture on Lower Urinary Tract Dysfunction in iNPH	N/A
Enrolling by invitation	`NCT03269201` - Brain Network Activation in Patients With Movement Disorders
Recruiting	`NCT03245138` - Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus	N/A
Terminated	`NCT00727142` - Conservative Versus Surgical Management of Idiopathic Normal Pressure Hydrocephalus (INPH)	N/A
Recruiting	`NCT04471740` - Normal Pressure Hydrocephalus and Sleep Apnea	N/A
Completed	`NCT01798641` - A Randomized Cross-over Study for Normal Pressure Hydrocephalus	N/A
Recruiting	`NCT01618500` - Computerised Testing of Cognitive Response to Cerebrospinal Fluid Shunting in Idiopathic Normal Pressure Hydrocephalus	N/A
Completed	`NCT00600795` - Prognostic Value of Transforming Growth Factor-Beta 1 in Normal Pressure Hydrocephalus	N/A
Terminated	`NCT03521518` - CPT-3 in Normal Pressure Hydrocephalus

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Cerebrospinal Fluid Proteome in Hydrocephalus — PROLIPHYC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms