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

July 11, 2023 updated by: University Hospital, Toulouse
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Magalie COLOMBAT

Study Locations

  • France
      • Toulouse, France, 31059
        • University Hospital of Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amylose typing
Amyloidosis typing by nanoLC-MS/MS in patients diagnosed with Amyloidosis but unable to be typed
Diagnostic test: Amyloidosis typing using mass spectrometry-based proteomics
Amyloidosis typing using nanoLC-MS/MS method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amyloidosis typing
Time Frame: Day 0
Amyloidosis typing rate with the new technique
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to return the result
Time Frame: Day 0
Time to return the result with the new technique (time in days)
Day 0
Concordance
Time Frame: Day 0
Agreement between the proteomic conclusion and the clinical judgement (binary answer : yes/no)
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

Centre National de la Recherche Scientifique, France

Investigators

  • Principal Investigator: Dominique CHAUVEAU, CHU Rangueil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2019

Primary Completion (Actual)

September 8, 2021

Study Completion (Actual)

September 8, 2021

Study Registration Dates

First Submitted

June 5, 2019

First Submitted That Met QC Criteria

June 12, 2019

First Posted (Actual)

June 13, 2019

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/16/8768

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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