CLEAR SSc
Research type
Research Study
Full title
Clinical Evaluation of sclerostin as a biomarker for fibrotic, vascular, and bone health in systemic sclerosis (CLEAR SSc)
IRAS ID
369858
Contact name
Michael Hughes
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Systemic sclerosis (SSc, also called scleroderma) is a rare connective tissue disease characterised by vasculopathy (damage to the blood vessels) and fibrosis (thickening/scarring) of the skin and internal organs; and is associated with significant mortality (death) and morbidity (loss of quality of life). Disease progression is highly variable between individuals with SSc and is hard to predict, with only limited biomarkers available for use in clinical practice.
Data relating to the role of sclerostin in SSc (including it’s use as a biomarker) is currently limited. However, small pilot studies have demonstrated that serum sclerostin levels are higher in patients with SSc when compared with healthy controls. Furthermore, higher serum sclerostin levels have been correlated with pulmonary (lung) complications and skin fibrosis. This pilot study will investigate the role of sclerostin further in patients with SSc and examine:
1) What are sclerostin levels in patients with SSc?
2) Does sclerostin correlate with fibrotic, vascular, and bone health in patients with SSc?To answer these questions, 100 patients with SSc will be recruited from Salford Royal Hospital, for a one-off study visit, lasting approximately 30 - 40 minutes. Patients will be asked to provide a blood sample in order to determine serum sclerostin levels, along with clinical details relating to their fibrotic, vascular and bone health, to correlate with sclerostin levels.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
26/WM/0116
Date of REC Opinion
22 May 2026
REC opinion
Further Information Favourable Opinion