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

Fundacion Clinic per a la Recerca Biomédica5,390 enrolled

Overview

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.

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

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

5,390

Conditions

Colorectal Cancer

Interventions

miRFec testDIAGNOSTIC_TEST

The miRFec test actually corresponds to the combination of fecal hemoglobin concentration (ie. FIT) and fecal miRNA expression

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Clinic of Barcelona

Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

Sensitivity for advanced colorectal neoplasm

To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced colorectal neoplasm