West Hertfordshire Inflammatory Bowel Disease Technology Study

NCT05000242 | Active Not Recruiting

• 1 other identifier: 20/LO/0349
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases

Keywords

Inflammatory Bowel Disease; Ulcerative Colitis; Crohns Disease; Artificial Intelligence; Endoscopy; Pathology; Radiology

Outcome Measures

Primary Outcomes (3)

• 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 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).

  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.

  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.

  24 months

• Performance of metrics will be assessed using Cohen's Kappa (k) and Inter-Class Correlation coefficient.

  24 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Perspectum: lead
• West Hertfordshire Hospitals NHS Trust: collaborator

Study Sites (1)

West Hertfordhsire Teaching Hospitals NHS Trust

Watford, Hertfordshire, WD18 0HB, United Kingdom

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Jonathan Landy

  West Hertfordshire Trust

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 11, 2021
• Study Start: January 31, 2022
• Primary Completion: January 31, 2026
• Study Completion: March 1, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

GB (1)