WHITS

• Research type

  Research Study

• Full title

  West Hertfordshire IBD technology study (WHITS)

• IRAS ID

  277729

• Contact name

  Jonathan Landy

• Contact email

  jonathan.landy@nhs.net

• Sponsor organisation

  Perspectum

• Duration of Study in the UK

  2 years, 0 months, 0 days

• Research summary

  The purpose of this research is to assess whether technology can be used to provide accurate diagnosis and assessment of IBD. We aim to develop computer generated quantitative methods from three diagnostic tools used in standard care for Inflammatory Bowel Diseases (IBD): endoscopy, radiology and histopathology. This is an observational study. Patients will be asked to consent for access to their medical records and for retrospective and prospective collection of information including videos of endoscopies, radiological images and histology that are undertaken in the course of their normal care. A subgroup will also be asked to consent to have additional histological assessment of biopsy tissue that has previously been acquired in the course of standard care.
  Participants will be enrolled in this study for a total of 12 months. Recruitment will be from clinics, endoscopy and the IBD database where prior consent for contact has been given. Participants will be screened and consented for study participation at outpatient clinics or the endoscopy department. Clinical data will be recorded as per usual practice by the IBD clinician. We will use some of this information for research and store it in a secure, bespoke database in a pseudonymised format. Patients will be given a patient information sheet (PIS) and consent form and be given as much time as needed to decide whether they want to take part. The person taking research consent will be qualified to do so (GCP training) and will be aware of the study requirements. Patient data will be stored on hospital computers and password protected at all times. Pseudonymised research data will be stored on a dedicated, secure research database maintained by Perspectum. No individuals will be identified in published data.

• REC name

  London - Queen Square Research Ethics Committee

• REC reference

  20/LO/0349

• Date of REC Opinion

  30 Mar 2020

• REC opinion

  Favourable Opinion