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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03984721

Acronym

TYPAMYL

Enrollment

Registered

2019-06-13

Start date

2019-07-25

Completion date

2021-09-08

Last updated

2023-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyloidosis

Keywords

Mass spectrometry based proteomic analysis, NanoLC-MS/MS, Amyloidosis typing

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.

Interventions

DIAGNOSTIC_TESTAmyloidosis typing using mass spectrometry-based proteomics

Amyloidosis typing using nanoLC-MS/MS method

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Inclusion of 40 patients identified by the Department of Anatomy and pathological cytology at the University of Toulouse.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Amyloidosis typing	Day 0	Amyloidosis typing rate with the new technique

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026