Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis

NCT ID: NCT02338427

Last Updated: 2018-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-11-30

Brief Summary

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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

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Conditions

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Amyloidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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proteomic

Group Type EXPERIMENTAL

Immunohistochemistry

Intervention Type OTHER

Proteomic analysis

Intervention Type OTHER

Interventions

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Immunohistochemistry

Intervention Type OTHER

Proteomic analysis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hervé MAISONNEUVE, PH

Role: STUDY_DIRECTOR

Centre Hospitalier Départementel Vendée

Locations

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Centre Hospitalier Departemental Vendee

La Roche-sur-Yon, , France

Site Status

CHU de Nantes

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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CHD 063-14

Identifier Type: -

Identifier Source: org_study_id