EUSTAR

• Research type

  Research Study

• Full title

  European Scleroderma Trials and Research group (EUSTAR)

• IRAS ID

  346778

• Contact name

  Maya Buch

• Contact email

  maya.buch@manchester.ac.uk

• Sponsor organisation

  University of Manchester

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  10 years, 0 months, 1 days

• Research summary

  Systemic sclerosis (SSc), otherwise known as scleroderma, is a rare autoimmune disease, affecting the skin, small blood vessels, and internal organs of the body, and can be extremely debilitating.

  The European Scleroderma Trials and Research group (EUSTAR) is an international research network, that coordinates efforts to improve the treatment, quality of life, and course of disease for people living with SSc.

  The main research tool of EUSTAR is a multi-centre, online database that allows for the prospective collection/analysis of data from patients with SSc. To date, more than 23,000 participants from over 250 International centres have been recruited. Such collaborative approaches are required when dealing with rare diseases. As well as contributing data, centres may apply themselves to access pseudonymised data from the EUSTAR database for research projects approved by EUSTAR for analysis.
  
  Longitudinal clinical and treatment data to be collected includes:

  • Disease subgroups
  • Autoantibodies
  • Disease signs and symptoms
  • Disease duration
  • Organ involvement
  • Laboratory results
  • Test results
  • Medications
  • Patient reported outcome measures

  Participants are required to sign a consent form in order to share their data with the EUSTAR collaboration.

  Participant’s information is updated annually, at their routine attendance of clinical appointments. The information is collected in clinic and later added to the database (taking around 60 minutes in total) and does not require a separate study visit. However, participants are free to withdraw from the study at any point without giving a reason and with no negative impact on their care or treatment.

  There are no fixed number of participants who can be recruited from any one centre and no fixed number of centres that can apply to join EUSTAR.

  This application seeks ethical approval for UK centres wishing to join EUSTAR. Currently, six hospital trusts (see section C - research sites) have expressed an interest to take part, with this number likely to increase over time.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  25/NW/0051

• Date of REC Opinion

  18 Mar 2025

• REC opinion

  Favourable Opinion