Inflammatory Bowel DiseasesWHITSNCT05000242
West Hertfordshire Inflammatory Bowel Disease Technology Study
An observational study of Inflammatory Bowel Diseases, run by Perspectum at 1 site in United Kingdom.
Trial summary
A retrospective and prospective, observational, non-interventional, cohort study to develop quantitative metrics from tools used as standard of care when diagnosing, assessing and monitoring patients with inflammatory bowel disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jan 2022to 30 Sep 2026
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: This research aims to develop digital tools specifically to aid patients with: 1. Left sided, extensive or Pan-colonic Ulcerative colitis, undergoing flexible sigmoidoscopy or colonoscopy 2. PaIleocolonic or colonic Crohn's disease undergoing flexible sigmoidoscopy or colonoscopy 3. Post-operative Crohn's disease undergoing colonoscopic assessment of surgical anastomosis 4. Ileal Crohn's disease undertaking or having previously undertaken small bowel CT or MRI 5. Crohn's disease with perianal disease undergoing or having previously undertaking pelvic MRI 6. A previous admission for acute severe ulcerative colitis
Who may be able to join
- Male or female aged 16 or over
- Patients with known or suspected Inflammatory Bowel Disease scheduled to undergo clinical, endoscopic or radiological assessment
- Patients with known Inflammatory Bowel Disease under ongoing clinical monitoring, who have previously undergone clinical, endoscopic or radiological assessments.
- Participant willing and able to give informed consent for participation in the study
Who cannot join
- Participant who is, or suspects that they are, pregnant at the time of assessment
- Any other cause, including significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the participant's ability to participate in the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
West Hertfordhsire Teaching Hospitals NHS Trust
Watford, Hertfordshire, WD18 0HB
About this study
A retrospective and prospective, observational, non-interventional, cohort study to develop quantitative metrics from tools used as standard of care when diagnosing, assessing and monitoring patients with inflammatory bowel disease.
Read the detailed description
Inflammatory bowel disease is a chronic inflammatory disease of the gastrointestinal tract that is without cure. It comprises two main disorders: Crohn's disease and ulcerative colitis. These conditions can lead to debilitating symptoms of abdominal pain, weight loss, diarrhoea and rectal bleeding.
The incidence of inflammatory bowel disease is increasing worldwide and is increasingly considered an emerging global disease. The prevalence of inflammatory bowel disease is currently the highest in North America and Western Europe and up to 600,000 people in the United Kingdom are thought to be affected.
The diagnosis and monitoring of inflammatory bowel disease is based on clinical, endoscopic, radiological and histological features. Endoscopy, is considered the current gold standard in inflammatory bowel disease with newer techniques being developed. There are however limitations to these methods, especially regarding the inter and intra observer variability in assessing the validated scoring systems used from the gold standard modalities.
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Inflammatory Bowel Disease, Ulcerative Colitis, Crohns Disease, Artificial Intelligence, Endoscopy, Pathology, Radiology
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Development and presentation of computer generated metrics derived from endoscopic videos.
To develop quantitative metrics from computational modelling of endoscopic, histological and radiological data by comparing clinical scores for inflammatory bowel disease between computer and human generated metrics to aid and improve assessment of inflammatory bowel disease.
Measured: 24 months
Development and presentation of computer - generated metrics derived from histology slides.
To develop quantitative metrics from computational modelling of endoscopic, histological and radiological data by comparing clinical scores for inflammatory bowel disease between computer and human generated metrics to aid and improve assessment of inflammatory bowel disease.
Measured: 24 months
Development and presentation of computer generated metrics derived from Magnetic Resonance Elastography/ Computerised Tomography Enterography / Magnetic Resonance Imaging Pelvis scans.
To develop quantitative metrics from computational modelling of endoscopic, histological and radiological data by comparing clinical scores for inflammatory bowel disease between computer and human generated metrics to aid and improve assessment of inflammatory bowel disease.
Measured: 24 months
Secondary outcomes (4)
The relation between human and computer generated metrics will be assessed using Cohen's Kappa (k) and correlation coefficients (Pearson's/Spearman's).
To determine whether quantitative metrics produced from digitised versions of inflammatory bowel disease investigatory tools accurately correspond to current standard care endoscopic, radiological and histological assessment in inflammatory bowel disease.
Measured: 24 months
Bland Altman analysis (bias, slope of bias, Limits of Agreement, the corresponding 95% Confidence Interval) and Inter-Class Correlation coefficients will be reported to estimate agreement between variables as endpoints for repeatability/reproducibility.
To compare repeatability and reproducibility of humangenerated and computer-generated metrics
Measured: 24 months
Statistical performance of computer diagnostic tools compared to clinical diagnoses: sensitivity, specificity, Area Under Receiver Operating Curve, predictive positive/negative value, survival curves with respect to clinical diagnosis/disease severity.
To determine the diagnostic and prognostic ability of the novel quantitative metrics to predict/diagnose clinical outcome data in addition to patient response to therapies and surgeries. This will be derived from historical and prospective endoscopic, imaging, clinical and histopathological data.
Measured: 24 months
Performance of metrics will be assessed using Cohen's Kappa (k) and Inter-Class Correlation coefficient.
To determine inter-observer and intra-observer variability in human-generated and computer generated metrics
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start31 Jan 2022
- Primary completion30 Jun 2024
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perspectum
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- West Hertfordshire Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Jonathan Landy, Study chair, West Hertfordshire Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000242
- Sponsor's protocol ID
- 20/LO/0349
- Acronym
- WHITS
- Status last verified
- May 2026
- First submitted
- 3 Aug 2021
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- West Hertfordshire Inflammatory Bowel Disease Technology Study
- ClinicalTrials.gov ID
- NCT05000242
- Acronym / sponsor ID
- WHITS / 20/LO/0349
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Inflammatory Bowel Disease, Ulcerative Colitis, Crohns Disease, Artificial Intelligence, Endoscopy, Pathology, Radiology
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- PerspectumIndustry (pharma, biotech, devices)
- Collaborators
- West Hertfordshire Hospitals NHS Trust
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 11 Aug 2021 (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.
A retrospective and prospective, observational, non-interventional, cohort study to develop quantitative metrics from tools used as standard of care when diagnosing, assessing and monitoring patients with inflammatory bowel disease.
Detailed description
Inflammatory bowel disease is a chronic inflammatory disease of the gastrointestinal tract that is without cure. It comprises two main disorders: Crohn's disease and ulcerative colitis. These conditions can lead to debilitating symptoms of abdominal pain, weight loss, diarrhoea and rectal bleeding.
The incidence of inflammatory bowel disease is increasing worldwide and is increasingly considered an emerging global disease. The prevalence of inflammatory bowel disease is currently the highest in North America and Western Europe and up to 600,000 people in the United Kingdom are thought to be affected.
The diagnosis and monitoring of inflammatory bowel disease is based on clinical, endoscopic, radiological and histological features. Endoscopy, is considered the current gold standard in inflammatory bowel disease with newer techniques being developed. There are however limitations to these methods, especially regarding the inter and intra observer variability in assessing the validated scoring systems used from the gold standard modalities.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This research aims to develop digital tools specifically to aid patients with: 1. Left sided, extensive or Pan-colonic Ulcerative colitis, undergoing flexible sigmoidoscopy or colonoscopy 2. PaIleocolonic or colonic Crohn's disease undergoing flexible sigmoidoscopy or colonoscopy 3. Post-operative Crohn's disease undergoing colonoscopic assessment of surgical anastomosis 4. Ileal Crohn's disease undertaking or having previously undertaken small bowel CT or MRI 5. Crohn's disease with perianal disease undergoing or having previously undertaking pelvic MRI 6. A previous admission for acute severe ulcerative colitis
Key inclusion criteria (4 listed)
- Male or female aged 16 or over
- Patients with known or suspected Inflammatory Bowel Disease scheduled to undergo clinical, endoscopic or radiological assessment
- Patients with known Inflammatory Bowel Disease under ongoing clinical monitoring, who have previously undergone clinical, endoscopic or radiological assessments.
- Participant willing and able to give informed consent for participation in the study
Key exclusion criteria (2 listed)
- Participant who is, or suspects that they are, pregnant at the time of assessment
- Any other cause, including significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the participant's ability to participate in the study
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
Development and presentation of computer generated metrics derived from endoscopic videos.
Time frame: 24 months
To develop quantitative metrics from computational modelling of endoscopic, histological and radiological data by comparing clinical scores for inflammatory bowel disease between computer and human generated metrics to aid and improve assessment of inflammatory bowel disease.
Development and presentation of computer - generated metrics derived from histology slides.
Time frame: 24 months
To develop quantitative metrics from computational modelling of endoscopic, histological and radiological data by comparing clinical scores for inflammatory bowel disease between computer and human generated metrics to aid and improve assessment of inflammatory bowel disease.
Development and presentation of computer generated metrics derived from Magnetic Resonance Elastography/ Computerised Tomography Enterography / Magnetic Resonance Imaging Pelvis scans.
Time frame: 24 months
To develop quantitative metrics from computational modelling of endoscopic, histological and radiological data by comparing clinical scores for inflammatory bowel disease between computer and human generated metrics to aid and improve assessment of inflammatory bowel disease.
4 secondary outcomes
The relation between human and computer generated metrics will be assessed using Cohen's Kappa (k) and correlation coefficients (Pearson's/Spearman's).
Time frame: 24 months
Bland Altman analysis (bias, slope of bias, Limits of Agreement, the corresponding 95% Confidence Interval) and Inter-Class Correlation coefficients will be reported to estimate agreement between variables as endpoints for repeatability/reproducibility.
Time frame: 24 months
Statistical performance of computer diagnostic tools compared to clinical diagnoses: sensitivity, specificity, Area Under Receiver Operating Curve, predictive positive/negative value, survival curves with respect to clinical diagnosis/disease severity.
Time frame: 24 months
Performance of metrics will be assessed using Cohen's Kappa (k) and Inter-Class Correlation coefficient.
Time frame: 24 months
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 22 May 2026.
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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. This study is not recruiting at the moment.
Jonathan Landy study chair
West Hertfordshire Trust
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 Inflammatory Bowel Diseases, run by Perspectum 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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development and presentation of computer generated metrics derived from endoscopic videos. (time frame: 24 months). The study lists 3 primary outcomes in all. 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 22 May 2026.