Amyloidosis Typing Using Mass Spectrometry-based Proteomics: a New Accurate Tool for Difficult Typing

NCT ID: NCT03984721

Last Updated: 2023-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-25

Study Completion Date

2021-09-08

Brief Summary

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The main objective is to establish that a new technique of amyloidosis typing by Proteomics (based on nanoLC-MS/MS mass spectrometry) allows typing in \> 90% of observations in patients whose Amyloidosis is reported to have failed typing (impossible typing, uncertain or inconsistent) with the traditional anatomopathological approach, and this in a cohort of 40 patients identified consecutively in the Department of pathological anatomy and cytology of the University Hospital of Toulouse and included prospectively.

Detailed Description

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Conditions

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Amyloidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Inclusion of 40 patients identified by the Department of Anatomy and pathological cytology at the University of Toulouse.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Amylose typing

Amyloidosis typing by nanoLC-MS/MS in patients diagnosed with Amyloidosis but unable to be typed

Group Type EXPERIMENTAL

Amyloidosis typing using mass spectrometry-based proteomics

Intervention Type DIAGNOSTIC_TEST

Amyloidosis typing using nanoLC-MS/MS method

Interventions

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Amyloidosis typing using mass spectrometry-based proteomics

Amyloidosis typing using nanoLC-MS/MS method

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Amyloidosis by Red Congo staining and birefringence in polarized light on tissue sampling
* Immunolabeling Amyloidosis typing

1. impossible (no frozen sample available)
2. or inconclusive (doubtful)
3. or inconsistent with clinical, biological, genetic and iconographic data
* Signature of the informed consent form

Exclusion Criteria

* Insufficient tissue material to perform the new technique
* Person placed under judicial protection
* Pregnant and breastfeeding women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dominique CHAUVEAU

Role: PRINCIPAL_INVESTIGATOR

CHU Rangueil

Locations

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University hospital of Toulouse

Toulouse, , France

Site Status

Countries

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France

References

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Vrana JA, Gamez JD, Madden BJ, Theis JD, Bergen HR 3rd, Dogan A. Classification of amyloidosis by laser microdissection and mass spectrometry-based proteomic analysis in clinical biopsy specimens. Blood. 2009 Dec 3;114(24):4957-9. doi: 10.1182/blood-2009-07-230722. Epub 2009 Oct 1.

Reference Type BACKGROUND
PMID: 19797517 (View on PubMed)

Theis JD, Dasari S, Vrana JA, Kurtin PJ, Dogan A. Shotgun-proteomics-based clinical testing for diagnosis and classification of amyloidosis. J Mass Spectrom. 2013 Oct;48(10):1067-77. doi: 10.1002/jms.3264.

Reference Type BACKGROUND
PMID: 24130009 (View on PubMed)

Other Identifiers

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RC31/16/8768

Identifier Type: -

Identifier Source: org_study_id

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