Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02338427

Acronym

IPA

Enrollment

140

Registered

2015-01-14

Start date

2016-05-31

Completion date

2018-11-30

Last updated

2018-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyloidosis

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.

Interventions

OTHERImmunohistochemistry

OTHERProteomic analysis

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Identification success of amylose by immunohistochemistry and proteomic analysis	Inclusion

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026