Early Diagnosis of SSc in the General Rheumatology Clinic - Pilot

NCT06291142 | Completed

• 2 other identifiers: R129030IRAS 315004
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational pilot data acquisition study is to establish if target users can obtain diagnostic quality images in the clinic, from participants with Systemic Sclerosis (SSc), and SSc spectrum conditions. The main questions it aims to answer are:

• Can a range of healthcare professionals, including non-specialists, use the capillaroscopy image acquisition system to take high quality images that can be used to create a clinical report?
• Can the investigators collect user and patient feedback on the usability of the capillaroscopy system, to help develop the software and to develop the clinical report
• Which microscope light source, from four different light wavelengths is better to see the blood vessels in skin with more melanin content. Participants will be asked to attend a single clinic visit where they will undergo a brief, non-invasive nailfold capillaroscopy examination, using the software-guided capillaroscopy system. Participants and rheumatology healthcare professionals will be invited to take part in one or more focus groups and interviews, to collect feedback and to contribute to the development of the image acquisition software and the clinical report.

Conditions

Systemic Sclerosis; Raynaud Phenomenon

Keywords

Raynaud's; Systemic Sclerosis Spectrum Disorder; Artificial Intelligence; Imaging; Capillaroscopy; Scleroderma

Outcome Measures

Primary Outcomes (1)

• Pilot Image Acquisition

  A set of nailfold capillaroscopy images from each participant

  11 months

Secondary Outcomes (2)

• Qualitative Feedback

  11 months

• Skin tone sub-study data set

  11 months

Study Arms (2)

Patient Participants

Patients with an SSc spectrum disorder, and healthy controls (objective 3)

Device: Observation - Nailfold capillaroscopy

Healthcare Professional Participants

Healthcare Professionals taking part in the qualitative element of the study

Device: Observation - Nailfold capillaroscopy

Interventions

Observation - Nailfold capillaroscopy DEVICE

Nailfold capillaroscopy examination

Healthcare Professional Participants; Patient Participants

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be identified by a review of patient medical records, or patients who present at a clinic appointment. Healthy controls (only applicable to the skin tone study at Salford Royal) will be identified via a database of previous volunteers, and via advertisements. Rheumatologists, vascular technicians, specialist nurses and other associated professionals required to take part in the focus groups and interviews will likely be those from each of the collaborating sites. They will be informed of the opportunity to take part during meetings with the research team and will be sent a participant information sheet via email.

You may qualify if:

• Image Acquisition:
• Children (aged between 6-17 years) and adults (aged 18 years and above) with Raynaud's phenomenon or a SSc- spectrum disorder.
• Qualitative aspect:
• Rheumatologists, vascular technicians, specialist nurses, or similar rheumatology trained professionals
• Patients with Raynaud's phenomenon and/or a SSc-spectrum disorder.
• Adults ages 18 years and over.

You may not qualify if:

• (Patients; image acquisition and skin tone study). Diabetes
• (Healthy controls). Requirement for vasoactive therapies
• (Healthy controls). Any condition known to affect the vasculature e.g. unregulated hypertension
• (All groups). Any disorder limiting the ability to provide informed consent or to comply with study requirements.

Sponsors & Collaborators

• University of Manchester: lead
• National Institute for Health Research, United Kingdom: collaborator
• Royal Bolton Hospital NHS Foundation Trust: collaborator
• Alder Hey Children's NHS Foundation Trust: collaborator
• University Hospitals of Morecambe Bay NHS Trust: collaborator
• Stockport NHS Foundation Trust: collaborator
• Medway NHS Foundation Trust: collaborator
• Northern Care Alliance NHS Foundation Trust: collaborator
• Royal Free Hospital NHS Foundation Trust: collaborator

Study Sites (1)

Northern Care Alliance NHS Foundation Trust

Salford, Salford, M6 8HD, United Kingdom

Location

Related Publications (1)

• Herrick AL, Berks M, Taylor CJ. Quantitative nailfold capillaroscopy-update and possible next steps. Rheumatology (Oxford). 2021 May 14;60(5):2054-2065. doi: 10.1093/rheumatology/keab006.

  PMID: 33493310 BACKGROUND

MeSH Terms

Conditions

Scleroderma, Systemic; Raynaud Disease; Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular

Study Officials

• Ariane E Herrick, MD, FRCP

  The University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: November 22, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 3, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)