Prospective, Multicenter, Comparative, Paired Study to Validate a microRNA-based Fecal Test for Colorectal Cancer Screening. The miRFec Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,390
- 试验地点
- 1
- 主要终点
- Sensitivity for advanced colorectal neoplasm
研究概览
简要总结
The present study aims to compare effectiveness and cost-effectiveness of the miRFec test with respect to fecal immunochemical test (FIT) for the detection of advanced colorectal neoplasm among individuals participating in colorectal cancer (CRC) screening, surveillance and diagnosis.
详细描述
The miRFec test -a Gradient Boosting Machine-generated algorithm that includes two fecal miRNAs (miR-421 and miR-27a-3p) and fecal hemoglobin concentration, along with age and gender- is more effective and cost-effective than FIT for the identification of patients with advanced colorectal neoplasm (i.e. colorectal cancer, advanced adenomas or advanced serrated lesions) among individuals participating in colorectal cancer screening and surveillance programs, and diagnosis.
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
- None
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 50 to 75 (average-risk) referred to colonoscopy-based CRC screening.
- •Male or female aged 30 to 80 with family history of CRC (moderate-risk) referred to colonoscopy-based CRC screening.
- •Male and female aged 18 or older with personal history of colorectal polyps referred to colonoscopy surveillance.
- •Male and female aged 18 or older with personal history of CRC referred to colonoscopy surveillance.
- •Male and female aged 18 or older with colorectal symptoms referred to diagnostic colonoscopy.
排除标准
- •Lack of informed consent to participate
- •Personal history of Lynch syndrome
- •Personal history of adenomatous or hamartomatous polyposis
- •Personal history of serrated polyposis syndrome
- •Personal history of inflammatory bowel disease
- •Personal history of total colectomy for any reason
- •Family history of Lynch syndrome
- •Family history of adenomatous or hamartomatous polyposis
- •Family history of serrated polyposis syndrome
研究组 & 干预措施
miRFec test
The miRFec test corresponds to the combination of fecal hemoglobin concentration and fecal miRNA expression
干预措施: miRFec test (Diagnostic Test)
结局指标
主要结局
Sensitivity for advanced colorectal neoplasm
时间窗: Through study completion, an average of 3 years
To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced colorectal neoplasm
次要结局
- Sensitivity for colorectal cancer(Through study completion, an average of 3 years)
- Sensitivity for advanced serrated lesions(Through study completion, an average of 3 years)
- Cost-effectiveness for advanced colorectal neoplasm detection(Through study completion, an average of 3 years)
- Sensitivity for advanced adenomas(Through study completion, an average of 3 years)
- Specificity(Through study completion, an average of 3 years)
- Discrimination capacity for advanced colorectal neoplasms(Through study completion, an average of 3 years)
- Detection rate for advanced colorectal neoplasm(Through study completion, an average of 3 years)
- Discrimination capacity for colorectal cancer(Through study completion, an average of 3 years)
研究者
Antoni Castells
Principal investigator
Fundacion Clinic per a la Recerca Biomédica