Anonymous Data Sharing for Small Bowel
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorUniversity College, London
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Have a clinical standard of reference within 6 weeks of the MRI scan
Patients with normal small bowel MRI studies and no clinical evidence of bowel pathology on any additional diagnostic investigations
Disqualifiers
Patients <16 or not fulfilling either inclusion criteria
Trial population
Anonymised datasets acquired as part of an ethically approved research project 'RESEARCH DATASETS': The investigators have two ongoing ethically approved UCLH studies investigating the use of MRI in small bowel Crohn's disease and comparison with clinical standards of reference, notably endoscopic biopsy, blood test data and clinical symptom diaries. As part of these projects, patients agree to their anonymised data to be used for future work. Anonymised datasets acquired as part of clinical practice 'CLINICAL DATASETS': Many patients undergoing small bowel MRI or USS at UCH and other collaborating hospitals often also undergo additional tests as part of the usual clinical care which are recognised as good standards of reference against which the investigators can validate their imaging findings.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
1,500 Participants
are grouped into 2 trial groupsGroup A: Anonymised datasets acquired as part of an ethically approved research project 'RESEARCH DATASETS':
Group B: Anonymised datasets acquired as part of clinical practice 'CLINICAL DATASETS'
Trial outcomes
Primary outcomes
1
Develop computer software to extract the bowel from the MRI dataset
measure parameters which reflect Crohn's disease activity which will be used to create and validate models of those parameters which best reflect disease activity.
Time frame
Through study completion, an average of 10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov