West Hertfordshire Inflammatory Bowel Disease Technology Study (WHITS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Inflammatory Bowel Diseases

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United Kingdom
  • Hertfordshire
    • Watford, Hertfordshire, United Kingdom, WD18 0HB
      • West Hertfordhsire Teaching Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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	24 months

Collaborators and Investigators

• Sponsor: Perspectum
• Collaborators: West Hertfordshire Hospitals NHS Trust
• Investigators: Study Chair: Jonathan Landy, West Hertfordshire Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Actual): June 30, 2024
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Inflammatory Bowel Disease; Endoscopy; Artificial Intelligence; Radiology; Pathology; Crohns Disease
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases
• Other Study ID Numbers: 20/LO/0349

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No