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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Diagnostic test: miRFec test

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 Type: Interventional
• Enrollment (Estimated): 5390
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mireia Diaz; Phone Number: 932275703; Email: mdiazc@clinic.cat

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic of Barcelona
    • Contact: Mireia Diaz; Phone Number: +34932275703; Email: mdiazc@clinic.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: miRFec test; The miRFec test corresponds to the combination of fecal hemoglobin concentration and fecal miRNA expression	Diagnostic test: miRFec test; The miRFec test actually corresponds to the combination of fecal hemoglobin concentration (ie. FIT) and fecal miRNA expression

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fundacion Clinic per a la Recerca Biomédica
• Investigators: Principal Investigator: Antoni Castells, MD, PhD, Hospital Clinic of Barcelona

Publications and helpful links

General Publications

• Duran-Sanchon S, Moreno L, Auge JM, Serra-Burriel M, Cuatrecasas M, Moreira L, Martin A, Serradesanferm A, Pozo A, Costa R, Lacy A, Pellise M, Lozano JJ, Gironella M, Castells A. Identification and Validation of MicroRNA Profiles in Fecal Samples for Detection of Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):947-957.e4. doi: 10.1053/j.gastro.2019.10.005. Epub 2019 Oct 14.
• Duran-Sanchon S, Moreno L, Gomez-Matas J, Auge JM, Serra-Burriel M, Cuatrecasas M, Moreira L, Serradesanferm A, Pozo A, Grau J, Pellise M, Gironella M, Castells A. Fecal MicroRNA-Based Algorithm Increases Effectiveness of Fecal Immunochemical Test-Based Screening for Colorectal Cancer. Clin Gastroenterol Hepatol. 2021 Feb;19(2):323-330.e1. doi: 10.1016/j.cgh.2020.02.043. Epub 2020 Feb 28.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: miRFec001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data that underlie results in a publication
• IPD Sharing Time Frame: After the end of the study
• IPD Sharing Access Criteria: Request to the study's principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No