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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03984721
Other study ID # RC31/16/8768
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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