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Completed

NCT Number: NCT03984721

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

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.

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Key information

Conditions

Amyloidosis Metabolic Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital of Toulouse

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amyloidosis typing using mass spectrometry-based proteomics

Diagnostic Test

Amyloidosis typing using nanoLC-MS/MS method

Primary outcomes

  1. Amyloidosis typing

    Time frame: Day 0

    Amyloidosis typing rate with the new technique

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Centre National de la Recherche Scientifique, France

Registry information

Acronym: TYPAMYL

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 13, 2019
Registry last updated
Jul 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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