Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis

NCT02338427 | Completed DMC

• 1 other identifier: CHD 063-14
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

Amyloidosis

Outcome Measures

Primary Outcomes (1)

• Identification success of amylose by immunohistochemistry and proteomic analysis

  Inclusion

Study Arms (1)

proteomic

EXPERIMENTAL

Other: Immunohistochemistry; Other: Proteomic analysis

Interventions

Immunohistochemistry OTHER

proteomic

Proteomic analysis OTHER

proteomic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Tissue sample inadequate for apply immunohistochemistry or proteomic identification
• Patient trust, guardianship, under legal protection measure, deprived of freedom

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (2)

Centre Hospitalier Departemental Vendee

La Roche-sur-Yon, 85925, France

Location

CHU de Nantes

Nantes, 44000, France

Location

MeSH Terms

Conditions

Amyloidosis

Interventions

Immunohistochemistry

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Study Officials

• Hervé MAISONNEUVE, PH

  Centre Hospitalier Départementel Vendée

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: January 14, 2015
• Study Start: May 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: December 24, 2018

Record last verified: 2018-12

Locations

FR (2)