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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02338427
Recruitment Status : Active, not recruiting
First Posted : January 14, 2015
Last Update Posted : August 23, 2018
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee

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.

Condition or disease Intervention/treatment Phase
Amyloidosis Other: Immunohistochemistry Other: Proteomic analysis Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis. Multicenter Prospective
Study Start Date : May 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis

Arm Intervention/treatment
Experimental: proteomic Other: Immunohistochemistry
Other: Proteomic analysis

Primary Outcome Measures :
  1. Identification success of amylose by immunohistochemistry and proteomic analysis [ Time Frame: Inclusion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02338427

Centre Hospitalier Departemental Vendee
La Roche sur Yon, France, 85925
CHU de Nantes
Nantes, France, 44000
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Study Director: Hervé MAISONNEUVE, PH Centre Hospitalier Départementel Vendée

Responsible Party: Centre Hospitalier Departemental Vendee Identifier: NCT02338427     History of Changes
Other Study ID Numbers: CHD 063-14
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Proteostasis Deficiencies
Metabolic Diseases