Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis (IPA)
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|ClinicalTrials.gov Identifier: NCT02338427|
Recruitment Status : Active, not recruiting
First Posted : January 14, 2015
Last Update Posted : August 23, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Amyloidosis||Other: Immunohistochemistry Other: Proteomic analysis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis. Multicenter Prospective|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||August 2019|
Other: Proteomic analysis
- Identification success of amylose by immunohistochemistry and proteomic analysis [ Time Frame: Inclusion ]
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): NCT02338427
|Centre Hospitalier Departemental Vendee|
|La Roche sur Yon, France, 85925|
|CHU de Nantes|
|Nantes, France, 44000|
|Study Director:||Hervé MAISONNEUVE, PH||Centre Hospitalier Départementel Vendée|