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

Toulouse University Hospital

Status: Completed

Conditions: Amyloidosis

Treatments: Diagnostic Test: Amyloidosis typing using mass spectrometry-based proteomics

Study type: Interventional

Funder types: Other

Identifiers

NCT03984721

RC31/16/8768

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Amylose typing

Experimental group

Description:

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

Treatment:

Diagnostic Test: Amyloidosis typing using mass spectrometry-based proteomics