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

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ClinicalTrials.gov Identifier: NCT03984721
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
Proteomics and Mass Spectrometry of Biomolecules, Proteomics Infrastructure of Toulouse
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Amyloidosis Diagnostic Test: Amyloidosis typing using mass spectrometry-based proteomics Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Inclusion of 40 patients identified by the Department of Anatomy and pathological cytology at the University of Toulouse.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Amyloidosis Typing Using Mass Spectrometry-based Proteomics: a New Accurate Tool for Difficult Typing
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis

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




Primary Outcome Measures :
  1. Amyloidosis typing [ Time Frame: Day 0 ]
    Amyloidosis typing rate with the new technique


Secondary Outcome Measures :
  1. Time to return the result [ Time Frame: Day 0 ]
    Time to return the result with the new technique (time in days)

  2. Concordance [ Time Frame: Day 0 ]
    Agreement between the proteomic conclusion and the clinical judgement (binary answer : yes/no)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984721


Contacts
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Contact: Magalie COLOMBAT 33-531156140 Colombat.Magali@iuct-oncopole.fr
Contact: Magalie COLOMBAT

Locations
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France
University hospital of Toulouse Not yet recruiting
Toulouse, France, 31059
Contact: Magalie COLOMBAT       Colombat.Magali@iuct-oncopole.fr   
Contact: Dominique CHAUVEAU       chauveau.d@chu-toulouse.fr   
Principal Investigator: Dominique CHAUVEAU         
Sub-Investigator: Stanislas FAGUER         
Sub-Investigator: Antoine HUART         
Sub-Investigator: David RIBES         
Sub-Investigator: Pascal CINTAS         
Sub-Investigator: Olivier LAIREZ         
Sub-Investigator: Laurent SAILLER         
Sponsors and Collaborators
University Hospital, Toulouse
Proteomics and Mass Spectrometry of Biomolecules, Proteomics Infrastructure of Toulouse
Investigators
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Principal Investigator: Dominique CHAUVEAU CHU Rangueil

Publications:
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03984721     History of Changes
Other Study ID Numbers: RC31/16/8768
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
Mass spectrometry based proteomic analysis
NanoLC-MS/MS
Amyloidosis typing

Additional relevant MeSH terms:
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Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases