West Hertfordshire Inflammatory Bowel Disease Technology Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Perspectum
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Development and presentation of computer generated metrics derived from endoscopic videos.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Development and presentation of computer generated metrics derived from endoscopic videos.
时间窗: 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.
Development and presentation of computer - generated metrics derived from histology slides.
时间窗: 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.
Development and presentation of computer generated metrics derived from Magnetic Resonance Elastography/ Computerised Tomography Enterography / Magnetic Resonance Imaging Pelvis scans.
时间窗: 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.
次要结局
- 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)
- Performance of metrics will be assessed using Cohen's Kappa (k) and Inter-Class Correlation coefficient.(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)