NCT06868875

Anonymous Data Sharing for Small Bowel

Recruiting now Last updated 11 March 2025

What this trial tests

trial in Small Bowel Disease in 1,500 participants. Currently enrolling.

Timeline

24 April 2011

Primary endpoint
31 August 2027

31 August 2027

Quick facts

Lead sponsor	University College, London
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	1,500
Start date	24 April 2011
Primary completion	31 August 2027
Estimated completion	31 August 2027
Sites	1 location across United Kingdom

Conditions studied

• Small Bowel Disease — all drugs for Small Bowel Disease →
• Gastrointestinal Diseases — all drugs for Gastrointestinal Diseases →

Sponsor

University College, London

Who can join

16 and older, any sex, with Small Bowel Disease or Gastrointestinal Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Crohn's disease is characterised by an abnormal immunological response within the bowel wall leading to abnormal wall thickening, stricturing (narrowing), fistulation (abnormal connections) to adjacent organs and strictures (narrowing), abnormal motility, and local sepsis (infection). Radiological imaging of the small bowel defines diagnosis, disease extent, biological activity and complications and is vital for timely and efficacious clinical management. Small bowel magnetic resonance imaging (MRI) does not impart ionising radiation and is proving to be a safe, well tolerated and robust method of assessing the small bowel and is widely implemented in the NHS and Europe. MRI evaluates multiple disease related features such as bowel wall thickness and motility which are proving increasing reliable for disease identification, staging, therapeutic guidance and assessment of treatment response.

Currently however radiologists must manually make these measurements which are time consuming and difficult.

There are no computer tools that can quickly and accurate make relevant measurements on MRI to guide patient management. Radiologists at University College Hospital have formed collaborations with groups within University College London (UCL) and around Europe. The investigators have received grant funding to develop computer software to accurately assess the small bowel using MRI over 3 years. To develop this software, it is necessary to use anonymised datasets from patients with and without Crohn's disease undergoing small bowel MRI. Part of this project will require prospective collection of MRI data which has been granted ethical approval as a major amendment to a currently running project (09/H0714/62). The department of Radiology at UCLH has been running a clinical small bowel MRI service since 2005 and have several hundred datasets on its PACS. This current ethics application seeks permission to datashare with the collaborative partners fully anonymised MRI datasets and relevant clinical data from patients previously undergoing small bowel MRI for clinical indications at UCLH.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.