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

NCT03984721 | Completed

• 1 other identifier: RC31/16/8768
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyloidosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Amyloidosis typing

  Amyloidosis typing rate with the new technique

  Day 0

Secondary Outcomes (2)

• Time to return the result

  Day 0

• Concordance

  Day 0

Study Arms (1)

Amylose typing

EXPERIMENTAL

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

Interventions

Amyloidosis typing using mass spectrometry-based proteomics DIAGNOSTIC_TEST

Amyloidosis typing using nanoLC-MS/MS method

Amylose typing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Insufficient tissue material to perform the new technique
• Person placed under judicial protection
• Pregnant and breastfeeding women

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Centre National de la Recherche Scientifique, France: collaborator

Study Sites (1)

University hospital of Toulouse

Toulouse, 31059, France

Location

Related Publications (2)

• Vrana JA, Gamez JD, Madden BJ, Theis JD, Bergen HR 3rd, Dogan A. Classification of amyloidosis by laser microdissection and mass spectrometry-based proteomic analysis in clinical biopsy specimens. Blood. 2009 Dec 3;114(24):4957-9. doi: 10.1182/blood-2009-07-230722. Epub 2009 Oct 1.

  PMID: 19797517 BACKGROUND

• Theis JD, Dasari S, Vrana JA, Kurtin PJ, Dogan A. Shotgun-proteomics-based clinical testing for diagnosis and classification of amyloidosis. J Mass Spectrom. 2013 Oct;48(10):1067-77. doi: 10.1002/jms.3264.

  PMID: 24130009 BACKGROUND

MeSH Terms

Conditions

Amyloidosis

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dominique CHAUVEAU

  CHU Rangueil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 13, 2019
• Study Start: July 25, 2019
• Primary Completion: September 8, 2021
• Study Completion: September 8, 2021
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)