Prelude Study: V 1.0 DNA analysis to assess genotypes
Research type
Research Study
Full title
A study to assess the genotype of subjects with diagnosis of ulcerative colitis or crohn's disease
IRAS ID
300926
Contact name
Sami Hoque
Contact email
Sponsor organisation
Prometheus Biosciences Inc
Duration of Study in the UK
2 years, 3 months, 31 days
Research summary
Blood sample for genetic analysis and serology will be collected from 6000 consented adult subjects who have a confirmed diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) and who fulfill the inclusion/exclusion criteria.
The samples will be analysed to determine the genotype frequency of specific gene sequences (halotypes) that are associated with the diagnosis (UC/CD) and to explore the association between subject characteristics and the identified halotypes. Research staff will also collect information on medical history, past and current medications and disease status.
The information may help improve the future treatment and/or testing of people with the disease.
Blood samples will be de-identified and maybe stored for up to 25 years after completion of the study for future irritable bowel disease (IBD) research or to support the development and validation of IBD diagnostic tests.REC name
North East - York Research Ethics Committee
REC reference
21/NE/0140
Date of REC Opinion
23 Jul 2021
REC opinion
Favourable Opinion