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

December 21, 2018 updated by: Centre Hospitalier Departemental Vendee

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Roche sur Yon, France, 85925
        • Centre Hospitalier Départemental Vendée
      • Nantes, France, 44000
        • CHU de Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: proteomic
Other: Immunohistochemistry
Other: Proteomic analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identification success of amylose by immunohistochemistry and proteomic analysis
Time Frame: Inclusion
Inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Departemental Vendee

Investigators

  • Study Director: Hervé MAISONNEUVE, PH, Centre Hospitalier Départementel Vendée

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

January 12, 2015

First Posted (Estimate)

January 14, 2015

Study Record Updates

Last Update Posted (Actual)

December 24, 2018

Last Update Submitted That Met QC Criteria

December 21, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD 063-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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