Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis (IPA)

Centre Hospitalier Departemental Vendee

Status: Completed

Conditions: Amyloidosis

Treatments: Other: Proteomic analysis; Other: Immunohistochemistry

Study type: Interventional

Funder types: Other

Identifiers

NCT02338427

CHD 063-14

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 1 patient group

proteomic

Experimental group

Treatment:

Other: Immunohistochemistry

Other: Proteomic analysis