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 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Normal Pressure Hydrocephalus||Biological: patient CSF extraction with hydrocephalus Biological: witness CSF extraction||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cerebrospinal Fluid Proteome in Hydrocephalus|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||December 2015|
patient CSF extraction with hydrocephalus
Biological: patient CSF extraction with hydrocephalus
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
- CSF proteome measure [ Time Frame: 48 hours ]CSF extraction (3 ml)
- correlation between CSF proteome and gait analysis [ Time Frame: 72 hours ]compare results from CSF proteome and gait analysis
- correlation between CSF proteome and MRI brain imaging [ Time Frame: 72 hours ]compare results from CSF proteome and brain imaging
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
|Toulouse, France, 31059|
|Principal Investigator:||Eric SCHMIDT, MD PhD||University Hospital, Toulouse|