The aim of this exciting MRC-funded project is to establish a research biobank of 500 patients with Primary Sjögren's syndrome for academic and clinical research as well as clinical trials. The project is organized by the UK Sjögren's Interest Group (UKSIG).
To facilitate high quality research and clinical trials of PSS, the Medical Research Council (MRC) has recently awarded the UK Sjögren's Interest Group (UKSIG) a sum of >£0.5 million to establish a cohort of 500 clinically well-characterised patients with Primary Sjögren's syndrome. Patients enrolled into the registry will be assessed for glandular and systemic disease activity and damage, level of fatigue and their health-related quality of life using standardised assessment tools. In addition, samples of serum, DNA and RNA from these patients will be stored. A cohort of age-, sex- and ethnicity-matched healthy controls will also be recruited simultaneously. There will be opportunities for recruiting centres to conduct and/or participate in add-on research projects, subject to approval by the steering committee and appropriate regulatory bodies. The registry is sponsored by the Newcastle upon Tyne Hospitals NHS Foundation Trust. The biobank will be housed in a secured facility within the Newcastle University.
Clinical data and biomaterials collection
Only linked anonymised data/biological materials will be stored. All clinical data will be collected using the UKPSSR proforma. Registered users can also submit the clinical data directly using a secured online portal via the UKPSSR website (www.sjogrensregistry.org.uk). Alternatively, completed proformas can be sent to UKPSSR by post. Blood samples will be collected for both clinical laboratory tests and extraction of various biological materials for storage. A dedicated senior research nurse based at the Freeman Hospital, Newcastle upon Tyne will be responsible for the co-ordination of data and sample collection, database maintenance and data analysis.
What is involved?
Patient recruitment commenced in August 2009 and there are currently over 25 centres across the UK involved in the project so far. If you are interested in joining or would like further information please contact Dr Wan-Fai Ng at email@example.com
All recruitment centres will need to:
- Register the study with their local R&D department (no separate R&D approval or Site-specific assessment is required however)
- Obtain Caldicott approval and
- Arrange a pre study visit with the Research Coordinator.