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

Not Applicable

Completed

• Conditions: Amyloidosis
• Interventions: Diagnostic Test: Amyloidosis typing using mass spectrometry-based proteomics

• Registration Number: NCT03984721
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-12
• Study First Posted: 2019-06-13
• Study Start: 2019-07-25
• Primary Completion: 2021-09-08
• Study Completion: 2021-09-08
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-11
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amylose typing	Amyloidosis typing using mass spectrometry-based proteomics	Amyloidosis typing by nanoLC-MS/MS in patients diagnosed with Amyloidosis but unable to be typed

Primary Outcome Measures

Name	Time	Method
Amyloidosis typing	Day 0	Amyloidosis typing rate with the new technique

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University hospital of Toulouse; 🇫🇷 Toulouse, France