Validation of a microRNA-based Fecal (miRFec) Test for Colorectal Cancer Screening

Study Overview
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Brief Summary
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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.

Detailed Description
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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 programs.

Official Title
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Prospective, Multicenter, Comparative, Parallel Study to Validate a microRNA-based Fecal Test for Colorectal Cancer Screening. The miRFec Study

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Diagnostic Test: miRFec test


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Lack of informed consent to participate Personal history of CRC, regardless when it was diagnosed Personal history of any other cancer in the last five years, except for non-melanoma skin cancer 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: Once the participant accepts to participate in the study, a fecal sample collection kit will be delivered together with the sample collection instructions. The sample must be collected at home before starting bowel preparation, more specifically between 24-72 hours before the day that colonoscopy is scheduled. Both miRNA expression and FIT will be analyzed in a central laboratory (Hospital Clinic of Barcelona) from the same fecal sample.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: miRFec test<br>The miRFec test corresponds to the combination of fecal hemoglobin concentration and fecal miRNA expression | Diagnostic Test: miRFec test<br>* The miRFec test actually corresponds to the combination of fecal hemoglobin concentration (ie. FIT) and fecal miRNA expression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity for advanced colorectal neoplasm | To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced colorectal neoplasm | Through study completion, an average of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity | To compare the specificity of the miRFec test with respect to FIT | Through study completion, an average of 3 years | 
| Sensitivity for colorectal cancer | To compare the sensitivity of the miRFec test with respect to FIT for the detection of colorectal cancer | Through study completion, an average of 3 years | 
| Sensitivity for advanced adenomas | To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced adenomas | Through study completion, an average of 3 years | 
| Sensitivity for advanced serrated lesions | To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced serrated lesions | Through study completion, an average of 3 years | 
| Detection rate for advanced colorectal neoplasm | To compare the detection rate for advanced colorectal neoplasm of the miRFec test with respect to FIT | Through study completion, an average of 3 years | 
| Discrimination capacity for advanced colorectal neoplasms | To compare the discrimination capacity of the miRFec score and fecal hemoglobin concentration for the detection of advanced colorectal neoplasm | Through study completion, an average of 3 years | 
| Discrimination capacity for colorectal cancer | To compare the discrimination capacity of the miRFec score and fecal hemoglobin concentration for the detection of colorectal cancer | Through study completion, an average of 3 years | 
| Cost-effectiveness for advanced colorectal neoplasm detection | To compare the cost (euros) for detecting one advanced colorectal neoplasm using the miRFec test with respect to the corresponding figure using FIT | Through study completion, an average of 3 years |