UK SMART database and tissue bank - Version 8, 31/01/2025

• Research type

  Research Tissue Bank

• IRAS ID

  354366

• Research summary

  UK SCLERODERMA COHORT (SMART) – DATA AND SAMPLE COLLECTION AND ANALYSIS
  

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  25/LO/0162

• Date of REC Opinion

  6 May 2025

• REC opinion

  Further Information Favourable Opinion

• Data collection arrangements

  This is a database recording information about disease characteristics in people with scleroderma-spectrum conditions, including systemic sclerosis (SSc), Raynaud's phenomenon and morphoea. Scleroderma is a rare condition causing thickening of the skin and in its systemic form it may cause scarring of the internal organs. Blood samples will be collected from people with scleroderma-spectrum conditions and from non-scleroderma controls, so that different blood markers can be compared in those with and without the disease.

  People with scleroderma-spectrum conditions who attend specialist centres that are part of this study, will be invited to consider if they would like to participate. They will be approached by physicians or nurses who are members of their direct care team. If a patient consents to participate, information about their date of birth, gender, ethnicity and details about their disease will be recorded in the database. All collected information and samples will be kept in coded form and only the patient’s direct care team will have access to the code.

  Some of the collected information and blood samples may be shared with academic centres outside this project or with pharmaceutical or biotechnology companies as part of collaborative research projects into scleroderma spectrum conditions. No information or samples will be released for profit and only storage and transportation costs will be recovered.

• Research programme

  All collected information and blood samples will be used for research into scleroderma and associated conditions. They will be used for projects that may be based in one or more of the centres that are part of this study. In addition, some of the information and samples will be shared with external collaborators. All study participants are invited to consider whether they would agree for their information and blood samples to be shared with centres outside this project. If they agree to this, some of their data and blood samples may be released to other centres that are members of the European League against Rheumatism (EULAR) Scleroderma Trials and Research organisation (EUSTAR, www.eustar.org). EUSTAR is an organisation that aims to increase awareness, understanding and research into scleroderma and its treatment. It has over 230 member centres that specialise in scleroderma-spectrum conditions.

• RTBTitle

  UK SCLERODERMA COHORT (SMART) – DATA AND SAMPLE COLLECTION AND ANALYSIS

• Establishment organisation

  University College London (UCL)

• Establishment organisation address

  Gower Street

  London

  WC1E 6BT