Small Bowel DiseaseNCT06868875
Anonymous Data Sharing for Small Bowel
An observational study of Small Bowel Disease and Gastrointestinal Diseases, run by University College, London at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Small Bowel Disease, Gastrointestinal Diseases
- How many people
- 1,500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Apr 2011to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients <16 or not fulfilling either inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Neela Ramchurn contact
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospital
London, NW1 2BU
Stuart Taylor, stuart.taylor@uclh.nhs.uk
Stuart Taylor
About this study
Official title: Data Sharing With Collaborative Partners to Develop Computer Aided Detection for the Assessment of the Small Bowel Using MRI
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.
Read the detailed description
The investigators wish to share with collaborative partners selected fully anonymized MRI datasets and associated relevant clinical data (such as blood tests results, endoscopic findings, histology) acquired as part of routine clinical practice at UCH since 2005.
The collaborative partners are:
- The Centre for Medical Image Computing (CMIC) at UCL
- A European consortium (including UCL as partner and UCLH as subcontractor) which has been awarded an FP7 European grant: University of Delph, Amsterdam medical centre, Eldgenössische Technische Hochschule Zürich, Switzerland, Zuse Institut Berlin, Germany, Biotronics3D Limited UK and Vodera Limited UK.
The investigators wish to share a total of 75 datasets with the FP7 consortium and 300 with CMIC.
Process for the sharing of anonymized datasets acquired as part of clinical practice.
Many patients undergoing small bowel MRI at UCH often also undergo additional tests as part of their usual clinical care which are recognized as good standards of reference against which the investigators can validate our MRI findings. Notable examples are blood tests (eg CRP), and endoscopy and biopsy. Furthermore, many patients have normal examinations and these datasets are also very useful in software development to define a standard of normality.
Suitable datasets will be found as follows:
- Search of the PACS database to identify all small bowel examinations performed at UCH
- Use clinical sources freely available to hospital clinical staff via the CDR web system at UCH to triage these patients into relevant clinical groups notably those who have normal small bowel examinations, and those with abnormal studies who have a relevant clinical standard of reference performed within 6 weeks (CRP level, endoscopy, biopsy)
- Select a sample of relevant datasets for use in software development. The total number to be data shared with the FP7 consortium listed above will not exceed 75. The total number of datasets to be data shared with UCL (CMIC) will not exceed 300. The larger number shared with CMIC reflects their need for a large database of normal examinations to develop motility software.
- Conditions
- Small Bowel Disease, Gastrointestinal Diseases
- Keywords
- Observational
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start24 Apr 2011
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart Taylor, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868875
- Sponsor's protocol ID
- 66975
- Status last verified
- Mar 2025
- First submitted
- 20 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Sharing With Collaborative Partners to Develop Computer Aided Detection for the Assessment of the Small Bowel Using MRI
- ClinicalTrials.gov ID
- NCT06868875
- Acronym / sponsor ID
- 66975
- Conditions
- Small Bowel Disease, Gastrointestinal Diseases
- Keywords
- Observational
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 24 Apr 2011 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators wish to share with collaborative partners selected fully anonymized MRI datasets and associated relevant clinical data (such as blood tests results, endoscopic findings, histology) acquired as part of routine clinical practice at UCH since 2005.
The collaborative partners are:
- The Centre for Medical Image Computing (CMIC) at UCL
- A European consortium (including UCL as partner and UCLH as subcontractor) which has been awarded an FP7 European grant: University of Delph, Amsterdam medical centre, Eldgenössische Technische Hochschule Zürich, Switzerland, Zuse Institut Berlin, Germany, Biotronics3D Limited UK and Vodera Limited UK.
The investigators wish to share a total of 75 datasets with the FP7 consortium and 300 with CMIC.
Process for the sharing of anonymized datasets acquired as part of clinical practice.
Many patients undergoing small bowel MRI at UCH often also undergo additional tests as part of their usual clinical care which are recognized as good standards of reference against which the investigators can validate our MRI findings. Notable examples are blood tests (eg CRP), and endoscopy and biopsy. Furthermore, many patients have normal examinations and these datasets are also very useful in software development to define a standard of normality.
Suitable datasets will be found as follows:
- Search of the PACS database to identify all small bowel examinations performed at UCH
- Use clinical sources freely available to hospital clinical staff via the CDR web system at UCH to triage these patients into relevant clinical groups notably those who have normal small bowel examinations, and those with abnormal studies who have a relevant clinical standard of reference performed within 6 weeks (CRP level, endoscopy, biopsy)
- Select a sample of relevant datasets for use in software development. The total number to be data shared with the FP7 consortium listed above will not exceed 75. The total number of datasets to be data shared with UCL (CMIC) will not exceed 300. The larger number shared with CMIC reflects their need for a large database of normal examinations to develop motility software.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients <16 or not fulfilling either inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Develop computer software to extract the bowel from the MRI dataset
Time frame: Through study completion, an average of 10 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Small Bowel Disease
RecruitingPhase 1
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
RecruitingObservational study
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Solid Tumor, Adult, Colorectal Cancer
RecruitingObservational study
Evaluation of Patients With Gastrointestinal Disease
Lower GI Disease, Gastrointestinal Diseases
Active, not recruitingPhase 1/2
Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments
Locally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung Cancer, Advanced Solid Tumors Harboring the KRAS G12C Mutation
RecruitingPhase 1
Phase 1 Study of STRO-006 in Adults With Refractory Solid Tumors That Are Recurrent or Metastatic
Head & Neck Squamous Cell Carcinoma, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neela Ramchurn contact
Stuart Taylor principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Bowel Disease and Gastrointestinal Diseases, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neela Ramchurn (n.ramchurn1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop computer software to extract the bowel from the MRI dataset (time frame: Through study completion, an average of 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.