Inflammatory Bowel Diseases Clinical Trial
— WHITSOfficial title:
West Hertfordshire Inflammatory Bowel Disease Technology Study
Verified date | January 2024 |
Source | Perspectum |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | March 1, 2024 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | West Hertfordhsire Teaching Hospitals NHS Trust | Watford | Hertfordshire |
Lead Sponsor | Collaborator |
---|---|
Perspectum | West Hertfordshire Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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