Faecal Immunochemical Tests (FIT) for Surveillance After Colorectal Cancer (CRC) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 主要终点
- Recurrent colorectal cancer or high-risk polyps
研究概览
简要总结
In the United Kingdom, over 25,000 patients have an operation for bowel cancer each year. After their operation, patients are monitored with a colonoscopy (camera test of the bowel) approximately 3 years after their operation, to look for any possible return of the cancer. Colonoscopies, and the bowel-cleaning medications needed, can be unpleasant for patients.
The Faecal Immunochemical Test (FIT) is a test to look for blood hidden in the poo. Blood in the poo can be a sign of bowel cancer, or a growth that can turn in to a cancer if left untreated (polyps). We currently use this test for bowel cancer screening, and to assess the risk of cancer in patients with bowel symptoms. You may have had a FIT when having tests for bowel cancer. We know this test is effective in picking up bowel cancer in these cases, but its use has not been assessed in following-up patients who have had treatment for bowel cancer previously.
For this study, we aim to see if a FIT stool sample test is accurate at diagnosing a return of bowel cancer for patients who have had a previous operation for bowel cancer. We want to see if using FIT could 'rule-out' cancer for some patients and be a potential alternative to colonoscopy for some patients in the future, allowing them to avoid this sometimes unpleasant test, which patient groups have told us is important for them.
Patients taking part in this study will have their usual treatment, including their colonoscopy (or sometimes a scan of the bowel), but will be asked to also provide a single FIT sample to assess how accurate this test is. The FIT sample is a quick and easy test of the poo that you can take at home and send to Nottingham University Hospitals NHS Trust (NUH) for testing. It should take no more than 5 to 10 minutes to take the sample, and a prepaid envelope is included to send the sample back to NUH for testing.
We aim to include at least 1,000 patients across 7 hospital trusts in the East Midlands.
详细描述
This is a diagnostic accuracy study, to assess the accuracy of FIT for predicting recurrence of CRC, or other significant pathology such as polyps and Inflammatory Bowel Disease (IBD), for patients undergoing their 3-year surveillance colonoscopy/CT Colon (CTC). Patients will be recruited from across 7 Hospital Trusts in the East Midlands. Eligible patients will be those adult patients who have had a curative operation for bowel cancer, due their surveillance colonoscopy/CTC. Patients with their entire colon removed, or with current ileostomy, will be excluded. The target would be for the patient to be recruited and complete their sample within the 3 months prior to the colonoscopy or CTC.
Eligible patients will be identified at each site and sent a postal study pack including Patient Information Sheet (PIS), consent form and FIT sampling kit. Patients agreeing to take part need only return the sample and consent form. They will go on to receive their normal care (surveillance colonoscopy or CTC), with the patients and clinicians responsible for their surveillance being blinded to the FIT result. The FIT samples will be analysed in NUH, and the results compared to the outcomes of the surveillance colonoscopies (or CTC) performed at the local Trusts. This will be used to see how accurate FIT is at predicting CRC recurrence, significant polyps and IBD. Patients will have no change to their normal care.
RESEARCH QUESTION / AIM(S) To assess how accurate a simple poo test (FIT) is in diagnosing bowel cancers and polyps (growths in the wall of the bowel) at high-risk of turning in to a cancer in patients who have had an operation for bowel cancer in the past.
Objectives
The primary objective is to assess the accuracy of FIT for recurrent colorectal cancer or high-risk polyps (high risk for turning in to a cancer if untreated) in patients having their 3-year surveillance colonoscopy/CTC after previous curative operation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years
- •Histological diagnosis of colorectal carcinoma
- •Previously treated by surgical resection with curative intent for colorectal carcinoma
- •Due whole-colon investigation for CRC follow-up as part of local routine care (Colonoscopy or CT colon)
排除标准
- •Patients under the age of 18
- •Patients unable to give valid informed consent
- •Patients with a current ileostomy, or no remaining colon after their operation (patients with colostomy will not be excluded)
- •Patients already diagnosed with recurrence of their colorectal cancer
结局指标
主要结局
Recurrent colorectal cancer or high-risk polyps
时间窗: Surveillance colonoscopy within 3 months of FIT sample
Presence of colorectal cancer (recurrent) or high-risk polyp (\>10mm, high-grade dysplasia) at 3-year surveillance colonoscopy or CT colon
次要结局
- Demographics of those not returning a FIT prior to surveillance colonoscopy(Surveillance colonoscopy within 3 months of FIT sample)
- Low-risk polyps or inflammatory bowel disease(Surveillance colonoscopy within 3 months of FIT sample)