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

Amyloidosis Clinical Trial

— TYPAMYL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03984721
• Other study ID #: RC31/16/8768
• Status: Completed
• Phase: N/A
• Start date: July 25, 2019
• Est. completion date: September 8, 2021

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 8, 2021
• Est. primary completion date: September 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis

Intervention

Diagnostic Test:
• Amyloidosis typing using mass spectrometry-based proteomics
Amyloidosis typing using nanoLC-MS/MS method

Locations

Country	Name	City	State
France	University hospital of Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Centre National de la Recherche Scientifique, France

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

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