Early Diagnosis of SSc in the General Rheumatology Clinic
Research type
Research Study
Full title
Early Diagnosis of Systemic Sclerosis in the General Rheumatology Clinic
IRAS ID
315004
Contact name
Ariane Herrick
Contact email
Sponsor organisation
The University of Manchester
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Systemic sclerosis (SSc) is a painful, disabling disease affecting around 20,000 people in the UK. Symptoms include painful ulcers on the fingers and toes, sometimes requiring amputation, and life-threatening internal organ damage. The first symptom of SSc is usually Raynaud’s phenomenon – white, painful fingers in the cold – though around 5% of otherwise healthy individuals also experience Raynaud’s. The National Institute for Health and Care Excellence (NICE) recommends that GPs should refer patients with Raynaud’s to a general rheumatology clinic for assessment. When a patient is referred for assessment, using nailfold capillaroscopy to find vessel abnormalities caused by SSc is recognised internationally as key to early diagnosis. Despite this, it is not used in most rheumatology clinics, because it requires expensive equipment and specialised skill. When capillaroscopy is not available, diagnosis is often delayed, which can have serious consequences for patients.
We will develop an artificial intelligence (AI) system that helps rheumatology clinics diagnose SSc as early as possible. The system will use nailfold capillaroscopy images of the small blood vessels at the base of the fingernails and digital technology to find changes due to disease. In a previous study we showed that, in expert hands, capillaroscopy images good enough to diagnose SSc can be obtained using a commercially available, hand-held microscope. We also developed AI image analysis software that finds capillary abnormalities very reliably.
This study will establish if target users can acquire diagnostic-quality images in clinic, and provide feedback to inform technology refinement. Images will be acquired using version one of our software from 105 patients across seven centres in England. We will also run workshops to gain qualitative input from users and patients to assess usability of the system. The results of this study will contribute to the development of a complete system suitable for use by non-specialists.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
23/PR/0945
Date of REC Opinion
6 Oct 2023
REC opinion
Further Information Favourable Opinion