Biomarkers of Disease Activity in Systemic Sclerosis - Nail Proteome
Research type
Research Study
Full title
Identifying Biomarkers of Disease Activity in Patients with Early Diffuse Cutaneous Systemic Sclerosis using the Nail Proteome
IRAS ID
284492
Contact name
Ariane Herrick
Contact email
Sponsor organisation
The University of Manchester
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Systemic sclerosis is a chronic, multi-system disorder characterised by thickening and fibrosis of the skin and internal organs. One of the main challenges in studying systemic sclerosis is to develop tools for accurately assessing disease activity. Identifying sensitive and reliable markers of disease activity would better enable physicians to: diagnose patients early, determine response to treatment and predict prognosis. Currently, there is no good “gold standard” measure of disease activity in systemic sclerosis.
This pilot study has been designed to determine if novel biomarkers of disease activity can be identified in the nail proteome (proteins found within the finger nail) of patients with systemic sclerosis.
20 patients with early diffuse cutaneous systemic sclerosis and 20 healthy volunteers will be recruited. Potential participants will be sent a pre-paid envelope containing the participant information sheet and sample collection tube. If willing, they will be asked to collect nail clippings at home and send them to the clinical recruitment team at Salford Royal NHS Foundation Trust. Samples will then be pseudonymised with a study number and passed on to researchers at the University of Manchester (Stopford Building) for analysis. Relevant patient details including disease duration, modified Rodnan skin scores and autoantibody status will be documented from the electronic record and from the Salford Systemic Sclerosis database. Demographic details including age, gender and ethnicity will be collected for both patients and healthy volunteers.
Participants' nail clippings will be analysed by mass spectroscopy to determine if differences in the nail proteome occur between patients and healthy volunteers. Any 'abnormalities' detected in the nail proteome of patients will be correlated with their modified Rodnan skin score (an already established marker of disease activity) to potentially identify novel biomarkers of disease activity in systemic sclerosis.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
20/YH/0340
Date of REC Opinion
11 Dec 2020
REC opinion
Further Information Favourable Opinion