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

Primary Purpose

Amyloidosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Immunohistochemistry
Proteomic analysis
Sponsored by
Centre Hospitalier Departemental Vendee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Amyloidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Departemental Vendee
  • CHU de Nantes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

proteomic

Arm Description

Outcomes

Primary Outcome Measures

Identification success of amylose by immunohistochemistry and proteomic analysis

Secondary Outcome Measures

Full Information

First Posted
January 12, 2015
Last Updated
December 21, 2018
Sponsor
Centre Hospitalier Departemental Vendee
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1. Study Identification

Unique Protocol Identification Number
NCT02338427
Brief Title
Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis
Acronym
IPA
Official Title
Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis. Multicenter Prospective
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyloidosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
proteomic
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Immunohistochemistry
Intervention Type
Other
Intervention Name(s)
Proteomic analysis
Primary Outcome Measure Information:
Title
Identification success of amylose by immunohistochemistry and proteomic analysis
Time Frame
Inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hervé MAISONNEUVE, PH
Organizational Affiliation
Centre Hospitalier Départementel Vendée
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier Departemental Vendee
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France

12. IPD Sharing Statement

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Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis

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