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OpenTrials
Active, Not Recruiting

NCT Number: NCT05000242

West Hertfordshire Inflammatory Bowel Disease Technology 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

West Hertfordhsire Teaching Hospitals NHS Trust

Watford, Hertfordshire, WD18 0HB, United Kingdom

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

    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.

  2. 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

    To compare repeatability and reproducibility of humangenerated and computer-generated metrics

  3. 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

    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.

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

    Time frame: 24 months

    To determine inter-observer and intra-observer variability in human-generated and computer generated metrics

Sponsors and collaborators

Lead sponsor

Perspectum

Industry

Collaborators

  • West Hertfordshire Hospitals NHS Trust

Registry information

Acronym: WHITS

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Aug 11, 2021
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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