Comparison of Performances of Two Automated Immunochemical Faecal Occult Blood Tests in Colorectal Cancer Screening, in Reference to Usual Care Guaiac Test
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 19,797
- 试验地点
- 4
- 主要终点
- Ratio of sensitivities (RSN) for detection of advanced neoplasias
研究概览
简要总结
Colorectal cancer screening by faecal occult blood test (FOBT) is a high public health priority. The interest of guaiac tests (G-FOBT) is limited by their poor sensitivity, while the superiority of I-FOBT in comparison with G-FOBT is now established. Nevertheless automated quantitative I-FOBTs have not been compared, and the optimal number of samples and threshold is not yet fixed. The aim of this study is to compare the performances of the 2 more well-known I-FOBTs with automated analyzers (magstream by Fujirebio, and OC Sensor by Eiken) for different positivity thresholds and numbers of samples in general average risk population. Patients will performed a two samples Magstream, a two samples OC Sensor and Hemoccult II. In case of a positive test, a colonoscopy will be performed. Sensitivity and specificity for detection of cancer and advanced neoplasias will be compared between tests using ratio of sensitivities (RSN) and ratio of false positives (RFP) according to number of samples and positivity threshold.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 to 74 years
- •Informed consent signed
排除标准
- •Recent digestive symptoms
- •Complete colonoscopy less than 5 years ago
- •Personal history of colorectal cancer or colorectal adenoma or colonic disease requiring regular colonoscopy surveillance
- •Familial history of colorectal cancer in a first degree next of kin before 65 years, or two cases in first degree next of kin.
- •Severe extra-intestinal disease
- •Screening ill-timed (ex. depression)
研究组 & 干预措施
Magstream + Oc Sensor + Hemoccult II
Each patient will perform all three tests:
- Magstream: 2 samples (each on a different stool)
- OC Sensor: 2 samples (each on a different stool)
- Hemoccult II: 6 samples (2 samples per stool, on 3 different stools)
Each test will be considered as positive if at least one sample is positive (cutoff for Magstream 55 ng/ml and for OC Sensor 150 ng/ml).
Screening will be considered as positive if at least one of the three tests is positive, leading to a colonoscopy
干预措施: Colonoscopy (Other)
结局指标
主要结局
Ratio of sensitivities (RSN) for detection of advanced neoplasias
时间窗: Up to 6 months after faecal occult blood test (FOBT) (At the time of colonoscopy)
Advanced neoplasias included invasive cancers and high-risk adenomas (larger than 1 cm or with high grade dysplasia). RSN is the ratio of the true positives of two tests. True positives for one test are patients positive for the test, with targeted lesion (here advanced neoplasias). RSN will be calculed between immunochemical tests, and for each immunochemical test in reference to gaiac test.
次要结局
- Predictive value for detection of advanced neoplasias(Up to 6 months after FOBT (At the time of colonoscopy))
- Detection rate of invasive cancer(Up to 6 months after FOBT (At the time of colonoscopy))
- Positivity rate(Immediate (At the time of FOBT))
- RFP for detection of advanced neoplasias(Up to 6 months after FOBT (At the time of colonoscopy))
- Relative Receiver Operating Characteristics(ROC) curves(Up to 6 months after FOBT (At the time of colonoscopy))
- Cost-effectiveness analysis(Up to 6 months after FOBT (At the time of colonoscopy))
- Ratio of False Positives (RFP) for detection of invasive cancers(Up to 6 months after FOBT (At the time of colonoscopy))
- Detection rate of advanced neoplasias(Up to 6 months after FOBT (At the time of colonoscopy))
- Predictive positive value for detection of invasive cancers(Up to 6 months after FOBT (At the time of colonoscopy))