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

NCT05346757 · Fundacion Clinic per a la Recerca Biomédica
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Official title
Prospective, Multicenter, Comparative, Paired Study to Validate a microRNA-based Fecal Test for Colorectal Cancer Screening. The miRFec Study
About this study
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.
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
Study design
Enrollment target: 5390 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-03-23
Estimated completion: 2027-01-31
Last updated: 2025-03-13
Interventions
Diagnostic Test: miRFec test
Primary outcomes
  • Sensitivity for advanced colorectal neoplasm (Through study completion, an average of 3 years)
Sponsor
Fundacion Clinic per a la Recerca Biomédica · other
Contacts & investigators
ContactMireia Diaz · contact · mdiazc@clinic.cat · 932275703
InvestigatorAntoni Castells, MD, PhD · principal_investigator, Hospital Clinic of Barcelona
All locations (1)
Hospital Clinic of BarcelonaRecruiting
Barcelona, Spain
Validation of a microRNA-based Fecal (miRFec) Test for Colorectal Cancer Screening, Surveillance and Diagnosis · TrialPath