Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2026-02-24 @ 11:20 AM
Study NCT ID:
NCT02338427
Status:
COMPLETED
Last Update Posted:
2018-12-24
First Post:
2015-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis
Sponsor:
Centre Hospitalier Departemental Vendee
Organization:
Study Overview
Official Title:
Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis. Multicenter Prospective
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IPA
Brief Summary:
Amyloidosis is involved in many rare diseases in relation to the diversity of amyloid proteins involved in the formation of abnormal tissue deposits. There are approximately 30 proteins involved in amylose's constitution. The therapeutic management varies depending on the type of amyloidosis observed.
The application of conventional techniques immunolabeling of amylose does not allow the comprehensive characterization of amylose forms, due to failures of the technic, the false positivity of some results, or lack of frozen tissue available for typing light chain (lambda, kappa).
In this study, the main objective is the comparison of two capacity of amylose characterisation: immunohistochemistry and proteomics analysis.
The purpose of this study is to validate the superiority of proteomic analysis by demonstrating the improvement of the precision, the reduction of technical failure, as well as the correction of erroneous diagnosis, authorizing a more adapted therapeutic management.
The application of conventional techniques immunolabeling of amylose does not allow the comprehensive characterization of amylose forms, due to failures of the technic, the false positivity of some results, or lack of frozen tissue available for typing light chain (lambda, kappa).
In this study, the main objective is the comparison of two capacity of amylose characterisation: immunohistochemistry and proteomics analysis.
The purpose of this study is to validate the superiority of proteomic analysis by demonstrating the improvement of the precision, the reduction of technical failure, as well as the correction of erroneous diagnosis, authorizing a more adapted therapeutic management.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: