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Recruiting NCT05346757

Validation of a microRNA-based Fecal (miRFec) Test for Colorectal Cancer Screening, Surveillance and Diagnosis

Trial Parameters

Condition Colorectal Cancer
Sponsor Fundacion Clinic per a la Recerca Biomédica
Study Type INTERVENTIONAL
Phase N/A
Enrollment 5,390
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2022-03-23
Completion 2027-01-31
Interventions
miRFec test

Brief 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 Criteria

Inclusion Criteria: * 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 Criteria: * 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

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