Testing a new fecal test for colorectal cancer detection
Official title: Prospective, Multicenter, Comparative, Paired Study to Validate a microRNA-based Fecal Test for Colorectal Cancer Screening. The miRFec Study
Run by Fundacion Clinic per a la Recerca Biomédica · NCT05346757 · Data updated 2026-11-12
This study is testing a new stool test for colorectal cancer to see if it works better and is more cost-effective than the standard test for people aged 50 to 75, especially those with a family history or personal history of colorectal issues.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 5390 (estimated) |
| Sponsor | Fundacion Clinic per a la Recerca Biomédica Academic / other |
| Locations | 1 site (Barcelona) |
| Status | Recruiting |
| Started | March 23, 2022 |
| Main results expected | January 31, 2027 |
| Study ends | January 31, 2027 |
| Registry record updated | March 13, 2025 |
| Trial ID | NCT05346757 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 50 to 75 at average risk or those aged 30 to 80 with a family history of colorectal cancer.
✕Probably not a fit
Patients with certain genetic syndromes or personal histories of specific polyposis syndromes or inflammatory bowel disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study compares the effectiveness and cost-effectiveness of a new microRNA-based fecal test (miRFec) against the traditional fecal immunochemical test (FIT) for detecting advanced colorectal neoplasms. The miRFec test utilizes a machine learning algorithm that incorporates specific fecal microRNAs, fecal hemoglobin concentration, age, and gender to improve detection rates. Participants include individuals aged 50 to 75 at average risk and those at moderate risk due to family history, as well as individuals with personal histories of colorectal issues. The goal is to enhance screening and surveillance methods for colorectal cancer.
Why it matters
Potential benefit: If successful, this test could provide a more effective and cost-efficient method for early detection of colorectal cancer.
How similar studies have gone: Other studies have shown promising results with similar microRNA-based approaches, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Hospital Clinic of Barcelona
Barcelona, Spain Recruiting
Study contacts
- Principal investigator: Antoni Castells, MD, PhD — Hospital Clinic of Barcelona
- Study coordinator: Mireia Diaz
- Email: mdiazc@clinic.cat
- Phone: 932275703
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Knife-assisted full-thickness resection for rectal lesions in a multicenter setting
A multicenter study tests knife-assisted full-thickness resection (kFTR) to remove rectal lesions in adults and see how well it works and how safe it is.
-
Personalized 3D Bioprinted Colorectal Cancer Microenvironment Model
This study tests patient-derived, 3D-bioprinted cancer models that include tumor, fibroblast, and immune cells to see if they can better predict how colorectal cancer will respond to treatment.
-
Integrated genomic and clinical database for cancer biomarker discovery
Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.
-
Prehabilitation with Resistance, Aerobic, or Both Before Colorectal Surgery
Four pre-surgery exercise options (resistance, aerobic, both, or none) will be tested to see which best reduces complications after colorectal cancer surgery.
-
Liver transplantation for colorectal cancer with liver metastases
This study follows adults with stage IV colorectal cancer whose disease is limited to the liver and who are getting a liver transplant as part of their cancer care to see how they fare over time.
-
LTZ-232: a first-in-human test in advanced colorectal and other solid tumors
A first-in-human study tests LTZ-232, a new therapy for adults with unresectable or metastatic colorectal cancer and other solid tumors that have not responded to standard treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.