The Performance of Faecal Immunochemical Test and Urinary Volatile Compounds in the Detection of Colorectal Adenomas and Their Role in Polyp Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Sensitivity of Faecal immunochemical test and urine volatile markers to detect colorectal adenomas
研究概览
简要总结
Bowel cancer can arise from polyps, which can become cancerous. Polyps are little outgrowths within the lining of the bowel (similar to skin warts). Depending on their size and their potential to become cancerous, they can cause bleeding. However, it is not known which polyps harbour cancerous potential. Therefore, at present all patients undergo a colonoscopy (camera examination of the large bowel) in order to identify and remove any polyps. However, not all patients who undergo a colonoscopy will have polyps. Moreover, colonoscopies are invasive and disruptive to patients, as they require bowel preparation. The aim of this study is to evaluate non-invasive stool and urine tests to identify patients who are at risk of polyps and if the polyps have the potential to become cancerous. This in turn, will significantly reduce the number of 'unnecessary' polyp surveillance colonoscopies with resultant benefits to both patients and the National Health Service (NHS).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are on a polyp surveillance programme and will be undergoing colonoscopy examination for polyp surveillance OR Patients who will be undergoing elective polypectomy through specialised polyp multi-disciplinary meetings.
排除标准
- •Participants who are unable to attend colonoscopy
- •Under 18 years old
- •Unable to provide informed consent for themselves to take part in this study
结局指标
主要结局
Sensitivity of Faecal immunochemical test and urine volatile markers to detect colorectal adenomas
时间窗: Through study completion, an average of 2 years
To determine the sensitivity of Faecal immunochemical test and urine volatile markers to detect colorectal adenomas - individually and in combination, in comparison to colonoscopy results (histology findings).
次要结局
- Positivity threshold for Faecal immunochemical test and urine volatile markers(Through study completion, an average of 2 years)
- Volatile chemicals in urine in those with adenomas(Through study completion, an average of 2 years)
- Sensitivity of Faecal immunochemical test and urine volatile markers for all adenomas and high-grade adenomas(Through study completion, an average of 2 years)
- To determine the sensitivity of blood markers for the detection of colorectal adenomas(Through study completion, an average of 2 years)