Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis

Amyloidosis Clinical Trial

— IPA  

Official title:

Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis. Multicenter Prospective

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02338427
• Other study ID #: CHD 063-14
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: November 2018

Study information

• Verified date: December 2018
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis

Intervention

Other:
• Immunohistochemistry

• Proteomic analysis

Locations

Country	Name	City	State
France	Centre Hospitalier Departemental Vendee	La Roche sur Yon
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification success of amylose by immunohistochemistry and proteomic analysis		Inclusion