Prospective, Multicenter, Comparative, Paired Study to Validate a microRNA-based Fecal Test for Colorectal Cancer Screening. The miRFec Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 5,390
- Locations
- 1
- Primary Endpoint
- Sensitivity for advanced colorectal neoplasm
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
miRFec test
The miRFec test corresponds to the combination of fecal hemoglobin concentration and fecal miRNA expression
Intervention: miRFec test (Diagnostic Test)
Outcomes
Primary Outcomes
Sensitivity for advanced colorectal neoplasm
Time Frame: 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
Secondary Outcomes
- 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)
Investigators
Antoni Castells
Principal investigator
Fundacion Clinic per a la Recerca Biomédica