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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04671446
Other study ID # IRAS 274097
Secondary ID 20/PR/0004
Status Recruiting
Phase
First received
Last updated
Start date December 10, 2020
Est. completion date June 2022

Study information

Verified date December 2020
Source Queen Mary University of London
Contact Laura Baseley
Phone +44 20 7882 6401
Email l.baseley@qmul.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this project the investigators will look for auto-antibodies to relevant proteins both in native form and importantly in post-translationally modified forms. Potential modified auto-antigens are eosinophil proteins (analogous to the cytoplasmic neutrophil proteins identified in vasculitides such as Granulomatosis with Polyangiitis (formerly known as Wegener's granulomatosis) and alternatively structural proteins such as collagen V. As well as advancing the understanding of asthma pathology, identifying a serum auto-antibody that could then be used as a clinical blood test, analogous to anti-cyclic citrullinated peptide (CCP) antibodies in rheumatoid arthritis, may revolutionise diagnosis of severe eosinophilic asthma and Eosinophilic Granulomatosis with Polyangiitis (EGPA). There is a considerable burden of undiagnosed severe eosinophilic asthma in part due to difficulties in definitive diagnosis and a diagnostic blood test would help diagnose these patients, allowing them to receive necessary treatment.


Description:

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Study Design


Intervention

Diagnostic Test:
Autoantibody ELISA
Serum will be tested for novel autoantibodies against eosinophil proteins by ELISA, such as those previously identified as of importance (e.g. eosinophil-peroxidase, EPX) and also novel candidate proteins specific to eosinophils (including ARFIP1, BCL2A1, PPCDC, SLC12A6 etc) as identified by FANTOM5 geneset analysis.

Locations

Country Name City State
United Kingdom Barts Health NHS Trust, Dept of Respiratory Medicine, St Bartholomew's Hospital London
United Kingdom Barts Health NHS Trust, Dept of Rheumatology, Mile End Hospital London

Sponsors (1)

Lead Sponsor Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Autoantibody positivity Positive OD by ELISA Baseline, at study entry
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