Testing a new fecal test for colorectal cancer detection
Prospective, Multicenter, Comparative, Paired Study to Validate a microRNA-based Fecal Test for Colorectal Cancer Screening. The miRFec Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5390 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fundacion Clinic per a la Recerca Biomédica Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05346757 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promising results with similar microRNA-based approaches, indicating potential for success.
Eligibility criteria
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 this trial is running
Barcelona
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.