Quantitative Immunochemical Fecal Occult Blood Test in Symptomatic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Number of patients with high fecal blood output in relation to colorectal cancer
研究概览
简要总结
The aim of this study is to compare the outcome of three (3) quantitative immunochemical faecal occult blood test in symptomatic patients.
详细描述
Consecutive patients referred from primary care for colonoscopy due to symptoms are eligible. Patients will receive written information of the study together with the time for colonoscopy. A specific research nurse will call them and for those accepting participation, history and current medication will be collected. Kits will be sent to patients and they will provide three faecal samples before examination. These will be analysed at one certified laboratory.
Hemoglobin concentration will be notified in the range of 50 - < 1000 ng/mL, or as a negative outcome.
Macroscopic findings at the colonoscopy will be collected, as well as the outcome of the pathological report.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Symptoms associated with colorectal cancer (anemia, change of bowel habits, diarrhoea, constipation, haematochezia, weight loss, anorexia)
排除标准
- •Screening investigations
- •High-risk patients
结局指标
主要结局
Number of patients with high fecal blood output in relation to colorectal cancer
时间窗: Up to 36 months
Accuracy of diagnosis in colorectal cancer
次要结局
- Number of patients with low fecal blood output in relation to colorectal polyps(Up to 36 months)