Strike
Research type
Research Study
Full title
Stratification for risk of progression in scleroderma (Strike)
IRAS ID
178638
Contact name
Francesco Del Galdo
Contact email
Sponsor organisation
The University of Leeds
Duration of Study in the UK
4 years, 11 months, 26 days
Research summary
Scleroderma is an extremely variable and rare disease which can affect the skin and internal organs. For some patients severe disability and death can occur within three years of diagnosis but for others it can remain completely benign. We are currently unable to predict the course of the disease and all patients are extensively screened in specialist rheumatology clinics every six months. Despite these regular appointments, we are unable to predict the disease trajectory. This study aims to develop a screening tool to: 1) identify the group of patients at risk of developing severe disease, 2) provide evidence based therapies for these at risk patients thereby preventing or delaying disease related complications such as multi-organ failure and, 3) prevent unnecessary investigations on patients who are not at risk of developing a severe form of scleroderma. In order to develop a screening tool, we need to collect sequential serum and imaging data from patients diagnosed with scleroderma and those at risk of developing scleroderma. This is a 5-year study, based in Leeds and includes five participating centres namely York, Harrogate, Bradford, Sheffield and UCL. The global target for this study is 800 patients.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
15/NE/0211
Date of REC Opinion
13 Jul 2015
REC opinion
Further Information Favourable Opinion