Anonymous Data Sharing for Small Bowel

NCT06868875 | Recruiting

• 1 other identifier: 66975
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Small Bowel Disease; Gastrointestinal Diseases

Keywords

Observational

Outcome Measures

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.

  Through study completion, an average of 10 years

Study Arms (2)

Anonymised datasets acquired as part of an ethically approved research project 'RESEARCH DATASETS':

We 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. Only staff on the delegation log for the original research project will have access to any psudeo-anonymised datasets acquired as part of that research. This is consistent with ICH Good Clinical Practice and local Research Governance procedures.

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 their usual clinical care which are recognised as good standards of reference against which we can validate our imaging findings. Notable examples are blood tests (eg. CRP), endoscopy and biopsy, and symptom questionnaires. Furthermore, many patients have normal examinations and these datasets are also very useful in software development to define a standard of normality. Only staff with full or honorary contracts and part of the clinical team at collaborating hospitals will have access to the clinical data and un-anonymised datasets. This is consistent with the situation presently as such staff already can access both the PACS and hospital CDR as part of their usual clinical practice

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Had a small bowel MRI at UCLH between 2005 and Sept 2010 as part of routine clinical practice who:
• 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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospital

London, NW1 2BU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Stuart Taylor

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neela Ramchurn

CONTACT

n.ramchurn1@nhs.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 11, 2025
• Study Start: April 24, 2011
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

GB (1)