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Completed

NCT Number: NCT02338427

Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis

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.

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Key information

Conditions

Amyloidosis Metabolic Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Departemental Vendee, La Roche-sur-Yon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

immunohistochemistry

Other

Proteomic analysis

Other

Primary outcomes

  1. Identification success of amylose by immunohistochemistry and proteomic analysis

    Time frame: Inclusion

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Registry information

Official study title

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

Acronym: IPA

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 14, 2015
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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