Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis

Not Applicable

Completed

• Conditions: Amyloidosis
• Interventions: Other: Immunohistochemistry; Other: Proteomic analysis

• Registration Number: NCT02338427
• Lead Sponsor: Centre Hospitalier Departemental Vendee

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-01-12
• Study First Posted: 2015-01-14
• Study Start: 2016-05
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-21
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Upper age to 18 years
• Amylose diagnosis establish by tissue sample, after "Rouge Congo" coloration
• All patient with amylose identified by the two laboratory of anatomopathology
• Sample necessary for realized proteomic analysis
• No opposition at the participation of the study
• Patient sign an informed consent for biology collection

Exclusion Criteria

• Tissue sample inadequate for apply immunohistochemistry or proteomic identification
• Patient trust, guardianship, under legal protection measure, deprived of freedom

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
proteomic	Proteomic analysis	-
proteomic	Immunohistochemistry	-

Primary Outcome Measures

Name	Time	Method
Identification success of amylose by immunohistochemistry and proteomic analysis	Inclusion

Trial Locations

Locations (2)

Centre Hospitalier Departemental Vendee; 🇫🇷 La Roche sur Yon, France

CHU de Nantes; 🇫🇷 Nantes, France