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CompletedNCT02338427IPAUpdated Dec 24, 2018

Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis

An interventional study of Immunohistochemistry and Proteomic analysis in Amyloidosis, sponsored by Centre Hospitalier Departemental Vendee. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-24.

Sponsored by Centre Hospitalier Departemental Vendee · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Amyloidosis

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03

In context

Amyloidosis

491 studies on the registry are indexed under Amyloidosis; 135 are open to participants now.

This study's enrollment of 140 is above the median of 40 across 304 interventional studies indexed under Amyloidosis.

Browse Amyloidosis studies →

Lead sponsor

Centre Hospitalier Departemental Vendee is the lead sponsor of 81 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
140 participants (actual)

Study arms

  • Experimental
    proteomic

    Other: Immunohistochemistry · Other: Proteomic analysis

Interventions

  • OtherImmunohistochemistry
  • OtherProteomic analysis
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What researchers measure

Primary outcomes

  1. Identification success of amylose by immunohistochemistry and proteomic analysis

    Time frame: Inclusion

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Study locations

2 sites
  • Centre Hospitalier Departemental Vendee
    La Roche sur Yon, 85925, France
  • CHU de Nantes
    Nantes, 44000, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02338427
Lead sponsor
Centre Hospitalier Departemental Vendee
Responsible party
Sponsor
First posted
Jan 14, 2015
Start date
May 2016
Primary completion
Nov 2018
Completion
Nov 2018
Last update
Dec 24, 2018

Study contacts

Hervé MAISONNEUVE, PH
study director · Centre Hospitalier Départementel Vendée

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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