Ireland
--:--IST
Recruiting Not applicable

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

NCT05346757 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2022-03-23
Last updated
2025-03-13

Condition(s) studied

Colorectal Cancer

Investigational drug(s) / intervention(s)

miRFec test

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
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

Primary outcome measure(s)

  • Sensitivity for advanced colorectal neoplasm — 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

Trial sites (1)

FacilityCityRegionStatus
Hospital Clinic of Barcelona Barcelona Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05346757 on ClinicalTrials.gov ↗ ← All trials in Spain