UK SMART database and tissue bank - Version 4, 16/01/2015

• Research type

  Research Tissue Bank

• IRAS ID

  159715

• Research summary

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

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  15/LO/0275

• Date of REC Opinion

  30 Mar 2015

• REC opinion

  Further Information Favourable Opinion

• Data collection arrangements

  This data base/ tissue bank will store demographic and clinical information as well as blood samples on systemic sclerosis patients seen in a number of specialist centres within the UK. Data stored will include date of birth, gender, ethnicity and diagnosis. We will also collect information on date of disease onset, details about the type of scleroderma and whether internal organs have been affected.

  Data will be updated through routine clinical reviews and participation will not involve any additional visits. All collected information will be coded – participants will receive a unique study number and only their direct care team will have access to the code.

  An additional blood sample will be taken for research, but this will be done at the same time as the blood for routine blood tests. The sample will be coded and participant’s identity will not be known to the researchers who process it.

  All data and samples will be kept in coded form (linked to donor but donor not identifiable to researchers).

  Potential participants will be identified among the patients attending the Systemic sclerosis outpatient clinics and among ward admissions. Informed consent will be obtained by physicians who are members of patients’ direct care team.

• Research programme

  The collected data and tissue will be used for research into systemic sclerosis and associated conditions. This will be done both within the SMART participating centres and with external collaborators. There are multiple ongoing scientific and clinical research projects into different aspects of systemic sclerosis in all participating centres. In addition, SMART provides a framework for collaboration with the European League against Rheumatism (EULAR) Scleroderma Trials and Research (EUSTAR, www.eustar.org) organisation. EUSTAR aims to foster the awareness, understanding and research of scleroderma and its management throughout Europe. The EUSTAR cohort database records information on a large number of patients with scleroderma from around 200 mostly European scleroderma centres. An ongoing large scale collaborative project is the Project to Decipher the Optimal Management of Systemic Sclerosis (DeSScipher). This is a multinational project aiming to improve the management of systemic sclerosis. Over its three-year duration, it will address prevention, early diagnosis, organ complications and treatment of SSc in adult and juvenile patients. UK centres have already recruited around 200 hundred patients and recruitment continues.

• Storage license

  N/A

• 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