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

Primary Purpose

Amyloidosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Amyloidosis typing using mass spectrometry-based proteomics
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Amyloidosis focused on measuring Mass spectrometry based proteomic analysis, NanoLC-MS/MS, Amyloidosis typing

Eligibility Criteria

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

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

Sites / Locations

  • University hospital of Toulouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Amylose typing

Arm Description

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

Outcomes

Primary Outcome Measures

Amyloidosis typing
Amyloidosis typing rate with the new technique

Secondary Outcome Measures

Time to return the result
Time to return the result with the new technique (time in days)
Concordance
Agreement between the proteomic conclusion and the clinical judgement (binary answer : yes/no)

Full Information

First Posted
June 5, 2019
Last Updated
July 11, 2023
Sponsor
University Hospital, Toulouse
Collaborators
Centre National de la Recherche Scientifique, France
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1. Study Identification

Unique Protocol Identification Number
NCT03984721
Brief Title
Amyloidosis Typing Using Mass Spectrometry-based Proteomics: a New Accurate Tool for Difficult Typing
Acronym
TYPAMYL
Official Title
Amyloidosis Typing Using Mass Spectrometry-based Proteomics: a New Accurate Tool for Difficult Typing
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 25, 2019 (Actual)
Primary Completion Date
September 8, 2021 (Actual)
Study Completion Date
September 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Centre National de la Recherche Scientifique, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyloidosis
Keywords
Mass spectrometry based proteomic analysis, NanoLC-MS/MS, Amyloidosis typing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Inclusion of 40 patients identified by the Department of Anatomy and pathological cytology at the University of Toulouse.
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amylose typing
Arm Type
Experimental
Arm Description
Amyloidosis typing by nanoLC-MS/MS in patients diagnosed with Amyloidosis but unable to be typed
Intervention Type
Diagnostic Test
Intervention Name(s)
Amyloidosis typing using mass spectrometry-based proteomics
Intervention Description
Amyloidosis typing using nanoLC-MS/MS method
Primary Outcome Measure Information:
Title
Amyloidosis typing
Description
Amyloidosis typing rate with the new technique
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Time to return the result
Description
Time to return the result with the new technique (time in days)
Time Frame
Day 0
Title
Concordance
Description
Agreement between the proteomic conclusion and the clinical judgement (binary answer : yes/no)
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Amyloidosis by Red Congo staining and birefringence in polarized light on tissue sampling Immunolabeling Amyloidosis typing impossible (no frozen sample available) or inconclusive (doubtful) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique CHAUVEAU
Organizational Affiliation
CHU Rangueil
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital of Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19797517
Citation
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.
Results Reference
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PubMed Identifier
24130009
Citation
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.
Results Reference
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Learn more about this trial

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

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