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

Fundacion Clinic per a la Recerca Biomédica

Status: Enrolling

Conditions: Colorectal Cancer

Treatments: Diagnostic Test: miRFec test

Study type: Interventional

Funder types: Other

Identifiers

NCT05346757

miRFec001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,390 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5,390 participants in 1 patient group

miRFec test

Other group

Description:

The miRFec test corresponds to the combination of fecal hemoglobin concentration and fecal miRNA expression

Treatment:

Diagnostic Test: miRFec test