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
About this trial
This is an interventional diagnostic trial for Amyloidosis
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
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
NCT ID
NCT02338427
First Posted
January 12, 2015
Last Updated
December 21, 2018
Sponsor
Centre Hospitalier Departemental Vendee
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
Learn more about this trial
Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis
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