Validation of a microRNA-based Fecal (miRFec) Test for Colorectal Cancer Screening, Surveillance and Diagnosis
Prospective, Multicenter, Comparative, Paired Study to Validate a microRNA-based Fecal Test for Colorectal Cancer Screening. The miRFec Study
Fundacion Clinic per a la Recerca Biomédica
5,390 participants
Mar 23, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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.
Exclusion Criteria9
- 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
Interventions
The miRFec test actually corresponds to the combination of fecal hemoglobin concentration (ie. FIT) and fecal miRNA expression
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05346757