IBD Bioresource
Research type
Research Study
Full title
The UK Inflammatory Bowel Disease BioResource: Progressing form Genetics to Function and Clinic Translation in Crohn’s Disease & Ulcerative Colitis in adults, young people and children
IRAS ID
173561
Contact name
Miles Parkes
Contact email
Sponsor organisation
Cambridge University Hospital NHS Foundation Trust
Duration of Study in the UK
9 years, 11 months, 30 days
Research summary
Working with the NIHR Bioresource, we are developing a centralised national recallable bioresource of 50,000 patients with Crohn's disease or ulcerative colitis (collectively inflammatory bowel disease / IBD) to support scientific and clinical IBD research. The paediatric IBD (PIBD) BioResource aims to recruit 800 paediatric IBD patients, including 150 newly diagnosed, to establish an overall resource of 5,000 paediatric onset IBD patients (incorporating adults who have already joined the IBD BioResource but had paediatric onset IBD).
Key features of IBD Bioresource:
1. DNA and serum + clinical and genetic data from IBD patients recruited UK-wide stored in a central biorepository funded by NIHR Bioresource
2. ewly diagnosed IBD patients. Detailed samples unconfounded by treatment or surgery, plus follow-up samples + clinical data
3. Recallability - run by the NIHR Bioresource office, allowing patients stratified by clinical subtype or carriage of specific IBD genetic risk variants to be recruited for stratified 'stage 2' scientific studies or clinical trials (each stage 2 study would require separate funding and new consent for each subject).IBD affects 4 per 1000 Europeans, peaking in young adults. Despite intensive medical therapies ~50% of patients require major surgery +/- colostomy for treatment failure or complications. There is a pressing need to understand the causes of IBD and develop better treatments.
Since 2007 we and others have identified> distinct genetic risk factors for IBD. The next steps require addional sequencing for rare variants and functional analysis, to understand how associated variants disturb cell function to cause IBD; and translation of this knowledge for clinical benefit. These require access to a large Bioresource of patients of known or ascertainable genotype, to obtain fresh samples for analysis or to recruit patients to stratified clinical trials.
'Recall-ability' is a key novel feature for our disease area. The ethical framework for this has been established by the NIHR Cambridge Bioresource which since 2007 has run a programme of ‘recallability-by-genotype’ for healthy individuals. Our IBD Bioresource will be part of the NIHR Bioresource, and will extend recallable functionality to IBD allowing translation of recent genetic advances.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
15/EE/0286
Date of REC Opinion
11 Nov 2015
REC opinion
Further Information Favourable Opinion