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.
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.
Lack of informed consent to participate
Personal history of Lynch syndrome
Personal history of adenomatous or hamartomatous polyposis
Personal history of serrated polyposis syndrome
Single group
miRFec test
Diagnostic testThe miRFec test actually corresponds to the combination of fecal hemoglobin concentration (ie. FIT) and fecal miRNA expression
Sensitivity for advanced colorectal neoplasm
To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced colorectal neoplasm
Specificity
To compare the specificity of the miRFec test with respect to FIT
Sensitivity for colorectal cancer
To compare the sensitivity of the miRFec test with respect to FIT for the detection of colorectal cancer
Sensitivity for advanced adenomas
To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced adenomas
Sensitivity for advanced serrated lesions
To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced serrated lesions
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