Clinical trial NCT05000242: West Hertfordshire Inflammatory Bowel Disease Technology Study
Official title: West Hertfordshire Inflammatory Bowel Disease Technology Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Inflammatory Bowel Diseases
Keywords: Inflammatory Bowel Disease
Ulcerative Colitis
Crohns Disease
Artificial Intelligence
Endoscopy
Pathology
Radiology
Lead sponsor: Perspectum
Sponsor class: INDUSTRY
Collaborators: name: West Hertfordshire Hospitals NHS Trust
First posted: 2021-08-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Development and presentation of computer generated metrics derived from endoscopic videos.
timeFrame: 24 months
measure: Development and presentation of computer - generated metrics derived from histology slides.
timeFrame: 24 months
measure: Development and presentation of computer generated metrics derived from Magnetic Resonance Elastography/ Computerised Tomography Enterography / Magnetic Resonance Imaging Pelvis scans.
timeFrame: 24 months
Secondary outcomes:
measure: The relation between human and computer generated metrics will be assessed using Cohen's Kappa (k) and correlation coefficients (Pearson's/Spearman's).
timeFrame: 24 months
measure: 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.
timeFrame: 24 months
measure: 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.
timeFrame: 24 months
measure: Performance of metrics will be assessed using Cohen's Kappa (k) and Inter-Class Correlation coefficient.
timeFrame: 24 months
Other outcomes:
Locations:
city: Watford
country: United Kingdom
facility: West Hertfordhsire Teaching Hospitals NHS Trust
state: Hertfordshire
Study officials:
References: